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A Study of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment-Naive Adults With Chronic Hepatitis C Virus (HCV) Genotype 1-6 Infection and Compensated Cirrhosis (EXPEDITION-8)

Primary Purpose

Hepatitis C Virus (HCV)

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Glecaprevir/Pibrentasvir
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C Virus (HCV) focused on measuring Hepatitis C Virus (HCV), Glecaprevir, Pibrentasvir, Treatment Naïve, Cirrhosis, Compensated Cirrhosis, Genotype (GT) 1-6, Pangenotypic, Chronic Hepatitis C Virus (HCV)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Screening laboratory result indicating Hepatitis C Virus (HCV) Genotype (GT) 1-6 infection.
  • Positive plasma HCV antibody and HCV RNA viral load greater than or equal to 1000 IU/mL at Screening.
  • Treatment-naive to any approved or investigational anti-HCV medication.
  • Participant must be documented as cirrhotic, with a Child-Pugh score of less than or equal to 6.

Exclusion Criteria:

  • Female participant who is pregnant, breastfeeding or is considering becoming pregnant during the study, or for approximately 30 days after the last dose of study drug.
  • Any current or historical clinical evidence of decompensated cirrhosis.
  • Positive test result at Screening for hepatitis B surface antigen (HBsAg), HBV deoxyribonucleic acid > lower limit of quantification (LLOQ) in subjects with isolated positive antibody to hepatitis B core antigen (anti-HBc) (i.e., negative HBsAg and anti-hepatitis B),or anti human immunodeficiency virus antibody (HIV Ab).
  • HCV genotype performed by the central laboratory during screening indicating co-infection with more than one HCV genotype.
  • History of suspected or confirmed hepatocellular carcinoma.

Sites / Locations

  • St. Josephs Hosp and Med Ctr /ID# 162762
  • Mayo Clinic Arizona /ID# 162314
  • Liver Wellness Center /ID# 162244
  • Felizarta /ID# 162295
  • VA Long Beach Healthcare System /ID# 162298
  • Usc /Id# 162248
  • Kaiser Permanente - San Diego (Palm Ave) /ID# 162289
  • Stanford University School of Med /ID# 162209
  • Cedars-Sinai Medical Center - West Hollywood /ID# 162313
  • University of Miami /ID# 162210
  • Triple O Research Institute /ID# 162300
  • Piedmont Hospital /ID# 162646
  • Northwestern University Feinberg School of Medicine /ID# 162208
  • Unity Point Health /ID# 162247
  • The University of Iowa Hospita /ID# 162214
  • University of Louisville /ID# 162242
  • Louisiana Research Ctr. LLC /ID# 162567
  • Mercy Medical Center /ID# 162291
  • Mayo Clinic - Rochester /ID# 162251
  • Southern Therapy and Advanced Research (STAR) LLC /ID# 162241
  • CHI Health Alegent Creighton /ID# 162286
  • Univ Nebraska Med Ctr /ID# 162285
  • Rnjms /Id# 162213
  • Montefiore Medical Center /ID# 162312
  • James J. Peters VA Medical Center /ID# 162644
  • Weill Cornell Medical College /ID# 161051
  • Icahn School of Med Mt. Sinai /ID# 162294
  • Duke University Medical Center /ID# 162299
  • Cumberland Research Assoc /ID# 162212
  • Carolinas Center for Liver Dis /ID# 162569
  • University Hospitals Cleveland /ID# 162243
  • Cleveland Clinic /ID# 162570
  • Osuchs /Id# 162284
  • Lehigh Valley Health Network /ID# 162603
  • Center for Liver Diseases, Oakland /ID# 162568
  • Vanderbilt Univ Med Ctr /ID# 162211
  • Texas Digestive Disease Consul /ID# 162648
  • University of Texas Health /ID# 162288
  • Virginia Commonwealth Univ /ID# 162215
  • Univ of Wisconsin Hosp/Clinics /ID# 162645
  • Tokuda Hospital Sofia /ID# 163422
  • DCC Fokus-5 - LZIP /ID# 163338
  • Univ Hosp for Active Treat /ID# 163330
  • UMHAT Sv. Ivan Rilski /ID# 163332
  • University of Calgary /ID# 161185
  • Percuro Clinical Research, Ltd /ID# 161184
  • Qe Ii Hsc /Id# 161178
  • The Ottawa Hospital Research /ID# 161179
  • Toronto General Hospital /ID# 161182
  • Research Site s.r.o /ID# 163020
  • KlinMed s.r.o. /ID# 162893
  • Institut Klinicke a Experimeth /ID# 162900
  • CHR Orleans - Hopital de la Source /ID# 163072
  • Hôpital Purpan /ID# 163065
  • CHU Amiens Picardie /ID# 163071
  • CHU Estaing /ID# 163058
  • Hospital Henri Mondor /ID# 163061
  • Hopital de la Croix Rousse /ID# 163073
  • General Hospital of Athens Laiko /ID# 162786
  • General and Oncology Hospital /ID# 162784
  • Reg Gen Univ Hosp Larissa /ID# 162783
  • Bioclinic Thessaloniki /ID# 162785
  • Budai Hepatologiai Centrum /ID# 166511
  • Szent Janos Korhaz /ID# 166542
  • St. James's Hospital /ID# 162619
  • St Vincent's Hospital /ID# 162617
  • Beaumont Hospital /ID# 162618
  • Tel Aviv Sourasky Medical Ctr /ID# 162185
  • Rambam Health Care Campus /ID# 162023
  • The Lady Davis Carmel MC /ID# 162017
  • Sheba Medical Center /ID# 162028
  • Universita della Campania Luigi Vanvitelli /ID# 162337
  • A.O.U. Policlinico S.Orsola-Malpighi /ID# 162335
  • ASST Grande Ospedale Metropolitano Niguarda /ID# 162340
  • Istituto Clinico Humanitas /ID# 162336
  • Polo Universitario Luigi Sacco /ID# 162339
  • Centrum Badan Klinicznych, Przychodnia Badan Klinicznych /ID# 162760
  • HepID - Diagnostyka I Terapia /ID# 162761
  • Uniwersytecki Szpital Kliniczn /ID# 162757
  • ID Clinic /ID# 162759
  • Centro Hosp de Lisboa Central /ID# 163770
  • Centro Hospitalar Lisboa Norte, EPE /ID# 163785
  • Centro Hospitalar do Porto EPE /ID# 163765
  • Centro Hospitalar de Sao Joao /ID# 163766
  • GHGCPR Research Institute /ID# 162608
  • Instituto de Investigacion Cientifica del Sur /ID# 162566
  • Klinical Investigations Group /ID# 162565
  • Institutul National de Boli Infectioase Prof. Dr. Matei Bals /ID# 163484
  • Institutul National de Boli Infectioase Prof. Dr. Matei Bals /ID# 164449
  • Institutul Clinic Fundeni /ID# 163479
  • Institutul Clinic Fundeni /ID# 163500
  • Institutul Nat. de Boli Infectioase /ID# 163488
  • LLC Medical Company Hepatolog /ID# 161998
  • CBSI Central scientific and research institute of epidemiology /ID# 161996
  • Central Clinical Hospital of R /ID# 163434
  • Stavropol State Medical Univ /ID# 161999
  • RSAHI Consulting and Diagnostic Centre /ID# 161995
  • Hospital Parc de Salut del Mar /ID# 162198
  • Hospital Univ Vall d'Hebron /ID# 162199
  • Hospital Universitario Reina S /ID# 162200
  • Hospital Donostia /ID# 162197
  • Hospital Univ Central Asturias /ID# 162195
  • China Medical University Hosp /ID# 162950
  • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 162949
  • Taipei Veterans General Hosp /ID# 162776
  • Basildon University Hospital /ID# 162616
  • The Royal Free Hospital /ID# 162614
  • North Manchester General /ID# 163945
  • Western General Hospital /ID# 162612
  • Queens Medical Centre /ID# 162615
  • National Hospital of Tropical Diseases /ID# 167974
  • Hoa Hao Medic Co. Ltd. /ID# 168178
  • Tropical Diseases Hospital /ID# 168211

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Glecaprevir (GLE)/Pibrentasvir (PIB) for 8 weeks

Arm Description

Glecaprevir (GLE)/Pibrentasvir (PIB) 300 mg/120 mg once daily (QD) for 8 weeks.

Outcomes

Primary Outcome Measures

Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Hepatitis C Virus (HCV) Genotype (GT) 1,2,4,5 and 6-infected Participants in the Per Protocol (PP) Population
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (<LLOQ; less than 15 IU/mL) 12 weeks after the last dose of study drug. Efficacy of the 8-week treatment duration compared to the historical 12-week treatment duration was demonstrated if the lower bound of the 2-sided 95% confidence interval (CI) for the percentage of participants with HCV GT1, GT2, GT4, GT5, or GT6 infection in the 8 week treatment duration achieving SVR12 was greater than 94% in the PP population. Efficacy analyses were performed following a fixed-sequence testing procedure to control the type I error rate. The percentage of participants achieving SVR12 was summarized with a 2-sided 95% CI, calculated using the normal approximation to the binomial distribution. If the number of participants who failed to achieve SVR12 rate was less than 5, the Wilson's score method was used to calculate the CI.
Percentage of Participants With SVR12 in HCV GT 1,2,4,5 and 6-infected Participants in the Intent-To-Treat (ITT) Population
SVR12 was defined as HCV RNA level less than the LLOQ (less than 15 IU/mL) 12 weeks after the last dose of study drug. Efficacy of the 8-week treatment duration compared to the historical 12-week treatment duration was demonstrated if the lower bound of the 2-sided 95% CI for the percentage of participants with HCV GT1, GT2, GT4, GT5, or GT6 infection in the 8 week treatment duration achieving SVR12 was greater than 93% in the ITT population. Primary efficacy analyses were performed following a fixed-sequence testing procedure to control the type I error rate. The percentage of participants achieving SVR12 was summarized with a 2-sided 95% CI, calculated using the normal approximation to the binomial distribution. If the number of participants who failed to achieve SVR12 rate was less than 5, the Wilson's score method was used to calculate the CI.

Secondary Outcome Measures

Percentage of Participants With SVR12 in HCV GT1-6-infected Participants in the PP Population
SVR12 was defined as HCV RNA level less than the LLOQ (less than 15 IU/mL) 12 weeks after the last dose of study drug. Efficacy of the 8-week treatment duration compared to the historical 12-week treatment duration was demonstrated if the lower bound of the 2-sided 95% CI for the percentage of participants with HCV GT1, GT2, GT3, GT4, GT5, or GT6 infection in the 8 week treatment duration achieving SVR12 was greater than 94% in the PP population. These efficacy analyses were performed only if success was demonstrated for both primary efficacy analyses, following a fixed-sequence testing procedure.
Percentage of Participants With SVR12 in HCV GT1-6-infected Participants in the ITT Population
SVR12 was defined as HCV RNA level less than the LLOQ (less than 15 IU/mL) 12 weeks after the last dose of study drug. Efficacy of the 8-week treatment duration compared to the historical 12-week treatment duration was demonstrated if the lower bound of the 2-sided 95% CI for the percentage of participants with HCV GT1, GT2, GT3, GT4, GT5, or GT6 infection in the 8 week treatment duration achieving SVR12 was greater than 93% in the ITT population. These efficacy analyses were performed only if success was demonstrated for both primary efficacy analyses, following a fixed-sequence testing procedure.
Percentage of Participants With On-treatment Virologic Failure in the ITT Population
On-treatment virologic failure was defined as confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.
Percentage of Participants With Post-treatment Relapse
Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment as planned (defined as study drug duration ≥ 52 days for participants assigned to 8 weeks of treatment) and with HCV RNA levels < LLOQ at the end of treatment excluding participants who had been reinfected.
Percentage of HCV GT3-infected Participants Who Achieved SVR12 in the PP Population
SVR12 was defined as HCV RNA level less than the LLOQ (less than 15 IU/mL) 12 weeks after the last dose of study drug.
Percentage of HCV GT3-infected Participants Who Achieved SVR12 in the ITT Population
SVR12 was defined as HCV RNA level less than the LLOQ (less than 15 IU/mL) 12 weeks after the last dose of study drug.

Full Information

First Posted
March 22, 2017
Last Updated
June 24, 2020
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT03089944
Brief Title
A Study of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment-Naive Adults With Chronic Hepatitis C Virus (HCV) Genotype 1-6 Infection and Compensated Cirrhosis
Acronym
EXPEDITION-8
Official Title
A Single Arm, Open-label Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment Naïve Adults With Chronic Hepatitis C Virus (HCV) Genotype 1-6 Infection and Compensated Cirrhosis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
April 28, 2017 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
November 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A Phase 3b, single arm, open-label, multicenter study in treatment naïve adults with chronic HCV infection and compensated cirrhosis to assess the safety of 8 weeks of treatment with glecaprevir/pibrentasvir and to demonstrate the efficacy of the sustained virologic response 12 weeks post dosing (SVR12) rates of 8 weeks of treatment with glecaprevir/pibrentasvir compared to the historical SVR12 rates of 12 weeks of treatment with glecaprevir/pibrentasvir.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C Virus (HCV)
Keywords
Hepatitis C Virus (HCV), Glecaprevir, Pibrentasvir, Treatment Naïve, Cirrhosis, Compensated Cirrhosis, Genotype (GT) 1-6, Pangenotypic, Chronic Hepatitis C Virus (HCV)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
343 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glecaprevir (GLE)/Pibrentasvir (PIB) for 8 weeks
Arm Type
Experimental
Arm Description
Glecaprevir (GLE)/Pibrentasvir (PIB) 300 mg/120 mg once daily (QD) for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Glecaprevir/Pibrentasvir
Other Intervention Name(s)
ABT-493, ABT-530
Intervention Description
Tablet
Primary Outcome Measure Information:
Title
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Hepatitis C Virus (HCV) Genotype (GT) 1,2,4,5 and 6-infected Participants in the Per Protocol (PP) Population
Description
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (<LLOQ; less than 15 IU/mL) 12 weeks after the last dose of study drug. Efficacy of the 8-week treatment duration compared to the historical 12-week treatment duration was demonstrated if the lower bound of the 2-sided 95% confidence interval (CI) for the percentage of participants with HCV GT1, GT2, GT4, GT5, or GT6 infection in the 8 week treatment duration achieving SVR12 was greater than 94% in the PP population. Efficacy analyses were performed following a fixed-sequence testing procedure to control the type I error rate. The percentage of participants achieving SVR12 was summarized with a 2-sided 95% CI, calculated using the normal approximation to the binomial distribution. If the number of participants who failed to achieve SVR12 rate was less than 5, the Wilson's score method was used to calculate the CI.
Time Frame
12 weeks after last dose of study drug
Title
Percentage of Participants With SVR12 in HCV GT 1,2,4,5 and 6-infected Participants in the Intent-To-Treat (ITT) Population
Description
SVR12 was defined as HCV RNA level less than the LLOQ (less than 15 IU/mL) 12 weeks after the last dose of study drug. Efficacy of the 8-week treatment duration compared to the historical 12-week treatment duration was demonstrated if the lower bound of the 2-sided 95% CI for the percentage of participants with HCV GT1, GT2, GT4, GT5, or GT6 infection in the 8 week treatment duration achieving SVR12 was greater than 93% in the ITT population. Primary efficacy analyses were performed following a fixed-sequence testing procedure to control the type I error rate. The percentage of participants achieving SVR12 was summarized with a 2-sided 95% CI, calculated using the normal approximation to the binomial distribution. If the number of participants who failed to achieve SVR12 rate was less than 5, the Wilson's score method was used to calculate the CI.
Time Frame
12 weeks after last dose of study drug
Secondary Outcome Measure Information:
Title
Percentage of Participants With SVR12 in HCV GT1-6-infected Participants in the PP Population
Description
SVR12 was defined as HCV RNA level less than the LLOQ (less than 15 IU/mL) 12 weeks after the last dose of study drug. Efficacy of the 8-week treatment duration compared to the historical 12-week treatment duration was demonstrated if the lower bound of the 2-sided 95% CI for the percentage of participants with HCV GT1, GT2, GT3, GT4, GT5, or GT6 infection in the 8 week treatment duration achieving SVR12 was greater than 94% in the PP population. These efficacy analyses were performed only if success was demonstrated for both primary efficacy analyses, following a fixed-sequence testing procedure.
Time Frame
12 weeks after last dose of study drug
Title
Percentage of Participants With SVR12 in HCV GT1-6-infected Participants in the ITT Population
Description
SVR12 was defined as HCV RNA level less than the LLOQ (less than 15 IU/mL) 12 weeks after the last dose of study drug. Efficacy of the 8-week treatment duration compared to the historical 12-week treatment duration was demonstrated if the lower bound of the 2-sided 95% CI for the percentage of participants with HCV GT1, GT2, GT3, GT4, GT5, or GT6 infection in the 8 week treatment duration achieving SVR12 was greater than 93% in the ITT population. These efficacy analyses were performed only if success was demonstrated for both primary efficacy analyses, following a fixed-sequence testing procedure.
Time Frame
12 weeks after the last dose of study drug
Title
Percentage of Participants With On-treatment Virologic Failure in the ITT Population
Description
On-treatment virologic failure was defined as confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.
Time Frame
8 weeks on treatment
Title
Percentage of Participants With Post-treatment Relapse
Description
Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment as planned (defined as study drug duration ≥ 52 days for participants assigned to 8 weeks of treatment) and with HCV RNA levels < LLOQ at the end of treatment excluding participants who had been reinfected.
Time Frame
Up to 12 weeks after the last dose of study drug
Title
Percentage of HCV GT3-infected Participants Who Achieved SVR12 in the PP Population
Description
SVR12 was defined as HCV RNA level less than the LLOQ (less than 15 IU/mL) 12 weeks after the last dose of study drug.
Time Frame
12 weeks after the last dose of study drug
Title
Percentage of HCV GT3-infected Participants Who Achieved SVR12 in the ITT Population
Description
SVR12 was defined as HCV RNA level less than the LLOQ (less than 15 IU/mL) 12 weeks after the last dose of study drug.
Time Frame
12 weeks after the last dose of study drug

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Screening laboratory result indicating Hepatitis C Virus (HCV) Genotype (GT) 1-6 infection. Positive plasma HCV antibody and HCV RNA viral load greater than or equal to 1000 IU/mL at Screening. Treatment-naive to any approved or investigational anti-HCV medication. Participant must be documented as cirrhotic, with a Child-Pugh score of less than or equal to 6. Exclusion Criteria: Female participant who is pregnant, breastfeeding or is considering becoming pregnant during the study, or for approximately 30 days after the last dose of study drug. Any current or historical clinical evidence of decompensated cirrhosis. Positive test result at Screening for hepatitis B surface antigen (HBsAg), HBV deoxyribonucleic acid > lower limit of quantification (LLOQ) in subjects with isolated positive antibody to hepatitis B core antigen (anti-HBc) (i.e., negative HBsAg and anti-hepatitis B),or anti human immunodeficiency virus antibody (HIV Ab). HCV genotype performed by the central laboratory during screening indicating co-infection with more than one HCV genotype. History of suspected or confirmed hepatocellular carcinoma.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AbbVie Inc.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
St. Josephs Hosp and Med Ctr /ID# 162762
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Mayo Clinic Arizona /ID# 162314
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Liver Wellness Center /ID# 162244
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72204
Country
United States
Facility Name
Felizarta /ID# 162295
City
Bakersfield
State/Province
California
ZIP/Postal Code
93301
Country
United States
Facility Name
VA Long Beach Healthcare System /ID# 162298
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Facility Name
Usc /Id# 162248
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Kaiser Permanente - San Diego (Palm Ave) /ID# 162289
City
San Diego
State/Province
California
ZIP/Postal Code
92154
Country
United States
Facility Name
Stanford University School of Med /ID# 162209
City
Stanford
State/Province
California
ZIP/Postal Code
94305-2200
Country
United States
Facility Name
Cedars-Sinai Medical Center - West Hollywood /ID# 162313
City
West Hollywood
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
University of Miami /ID# 162210
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Triple O Research Institute /ID# 162300
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407-3100
Country
United States
Facility Name
Piedmont Hospital /ID# 162646
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Northwestern University Feinberg School of Medicine /ID# 162208
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-2927
Country
United States
Facility Name
Unity Point Health /ID# 162247
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
The University of Iowa Hospita /ID# 162214
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Louisville /ID# 162242
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Louisiana Research Ctr. LLC /ID# 162567
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105-6800
Country
United States
Facility Name
Mercy Medical Center /ID# 162291
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Facility Name
Mayo Clinic - Rochester /ID# 162251
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905-0001
Country
United States
Facility Name
Southern Therapy and Advanced Research (STAR) LLC /ID# 162241
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
CHI Health Alegent Creighton /ID# 162286
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68124
Country
United States
Facility Name
Univ Nebraska Med Ctr /ID# 162285
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Rnjms /Id# 162213
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Montefiore Medical Center /ID# 162312
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
James J. Peters VA Medical Center /ID# 162644
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States
Facility Name
Weill Cornell Medical College /ID# 161051
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Icahn School of Med Mt. Sinai /ID# 162294
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Duke University Medical Center /ID# 162299
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710-3000
Country
United States
Facility Name
Cumberland Research Assoc /ID# 162212
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
Country
United States
Facility Name
Carolinas Center for Liver Dis /ID# 162569
City
Statesville
State/Province
North Carolina
ZIP/Postal Code
28677-3471
Country
United States
Facility Name
University Hospitals Cleveland /ID# 162243
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Cleveland Clinic /ID# 162570
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44111
Country
United States
Facility Name
Osuchs /Id# 162284
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74127
Country
United States
Facility Name
Lehigh Valley Health Network /ID# 162603
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Center for Liver Diseases, Oakland /ID# 162568
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Vanderbilt Univ Med Ctr /ID# 162211
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-0011
Country
United States
Facility Name
Texas Digestive Disease Consul /ID# 162648
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246-1613
Country
United States
Facility Name
University of Texas Health /ID# 162288
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-1501
Country
United States
Facility Name
Virginia Commonwealth Univ /ID# 162215
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Facility Name
Univ of Wisconsin Hosp/Clinics /ID# 162645
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-0001
Country
United States
Facility Name
Tokuda Hospital Sofia /ID# 163422
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
DCC Fokus-5 - LZIP /ID# 163338
City
Sofia
ZIP/Postal Code
1463
Country
Bulgaria
Facility Name
Univ Hosp for Active Treat /ID# 163330
City
Sofia
ZIP/Postal Code
1527
Country
Bulgaria
Facility Name
UMHAT Sv. Ivan Rilski /ID# 163332
City
Sofia
ZIP/Postal Code
1612
Country
Bulgaria
Facility Name
University of Calgary /ID# 161185
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
Percuro Clinical Research, Ltd /ID# 161184
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8V 3M9
Country
Canada
Facility Name
Qe Ii Hsc /Id# 161178
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
The Ottawa Hospital Research /ID# 161179
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Toronto General Hospital /ID# 161182
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
Research Site s.r.o /ID# 163020
City
Plzen
ZIP/Postal Code
301 00
Country
Czechia
Facility Name
KlinMed s.r.o. /ID# 162893
City
Prague
ZIP/Postal Code
120 00
Country
Czechia
Facility Name
Institut Klinicke a Experimeth /ID# 162900
City
Prague
ZIP/Postal Code
140 21
Country
Czechia
Facility Name
CHR Orleans - Hopital de la Source /ID# 163072
City
Orleans CEDEX 2
State/Province
Centre-Val De Loire
ZIP/Postal Code
45067
Country
France
Facility Name
Hôpital Purpan /ID# 163065
City
TOULOUSE Cedex 9
State/Province
Haute-Garonne
ZIP/Postal Code
31059
Country
France
Facility Name
CHU Amiens Picardie /ID# 163071
City
Amiens CEDEX 1
State/Province
Somme
ZIP/Postal Code
80054
Country
France
Facility Name
CHU Estaing /ID# 163058
City
Clermont Ferrand
ZIP/Postal Code
63100
Country
France
Facility Name
Hospital Henri Mondor /ID# 163061
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Hopital de la Croix Rousse /ID# 163073
City
Lyon
ZIP/Postal Code
69004
Country
France
Facility Name
General Hospital of Athens Laiko /ID# 162786
City
Athens
State/Province
Attiki
ZIP/Postal Code
115 27
Country
Greece
Facility Name
General and Oncology Hospital /ID# 162784
City
Kifissia
ZIP/Postal Code
14564
Country
Greece
Facility Name
Reg Gen Univ Hosp Larissa /ID# 162783
City
Larisa
ZIP/Postal Code
41110
Country
Greece
Facility Name
Bioclinic Thessaloniki /ID# 162785
City
Thessaloniki
ZIP/Postal Code
54622
Country
Greece
Facility Name
Budai Hepatologiai Centrum /ID# 166511
City
Budapest
ZIP/Postal Code
1111
Country
Hungary
Facility Name
Szent Janos Korhaz /ID# 166542
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
St. James's Hospital /ID# 162619
City
Dublin 8
State/Province
Dublin
ZIP/Postal Code
D08 E9P6
Country
Ireland
Facility Name
St Vincent's Hospital /ID# 162617
City
Dublin 4
Country
Ireland
Facility Name
Beaumont Hospital /ID# 162618
City
Dublin
ZIP/Postal Code
D09 XR63
Country
Ireland
Facility Name
Tel Aviv Sourasky Medical Ctr /ID# 162185
City
Tel Aviv-Yafo
State/Province
Tel-Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Rambam Health Care Campus /ID# 162023
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
The Lady Davis Carmel MC /ID# 162017
City
Haifa
ZIP/Postal Code
3436212
Country
Israel
Facility Name
Sheba Medical Center /ID# 162028
City
Ramat Gan
ZIP/Postal Code
5262100
Country
Israel
Facility Name
Universita della Campania Luigi Vanvitelli /ID# 162337
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
A.O.U. Policlinico S.Orsola-Malpighi /ID# 162335
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40138
Country
Italy
Facility Name
ASST Grande Ospedale Metropolitano Niguarda /ID# 162340
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20162
Country
Italy
Facility Name
Istituto Clinico Humanitas /ID# 162336
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Polo Universitario Luigi Sacco /ID# 162339
City
Milan
ZIP/Postal Code
20157
Country
Italy
Facility Name
Centrum Badan Klinicznych, Przychodnia Badan Klinicznych /ID# 162760
City
Wrocław
State/Province
Dolnoslaskie
ZIP/Postal Code
50-349
Country
Poland
Facility Name
HepID - Diagnostyka I Terapia /ID# 162761
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-884
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczn /ID# 162757
City
Bialystok
ZIP/Postal Code
15-276
Country
Poland
Facility Name
ID Clinic /ID# 162759
City
Myslowice
ZIP/Postal Code
41-406
Country
Poland
Facility Name
Centro Hosp de Lisboa Central /ID# 163770
City
Lisbon
State/Province
Lisboa
ZIP/Postal Code
1169-050
Country
Portugal
Facility Name
Centro Hospitalar Lisboa Norte, EPE /ID# 163785
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Centro Hospitalar do Porto EPE /ID# 163765
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Centro Hospitalar de Sao Joao /ID# 163766
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
GHGCPR Research Institute /ID# 162608
City
Ponce
ZIP/Postal Code
00716
Country
Puerto Rico
Facility Name
Instituto de Investigacion Cientifica del Sur /ID# 162566
City
Ponce
ZIP/Postal Code
00730
Country
Puerto Rico
Facility Name
Klinical Investigations Group /ID# 162565
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
Facility Name
Institutul National de Boli Infectioase Prof. Dr. Matei Bals /ID# 163484
City
Sector 2
State/Province
Bucuresti
ZIP/Postal Code
021105
Country
Romania
Facility Name
Institutul National de Boli Infectioase Prof. Dr. Matei Bals /ID# 164449
City
Sector 2
State/Province
Bucuresti
ZIP/Postal Code
021105
Country
Romania
Facility Name
Institutul Clinic Fundeni /ID# 163479
City
Sector 2
State/Province
Bucuresti
ZIP/Postal Code
022328
Country
Romania
Facility Name
Institutul Clinic Fundeni /ID# 163500
City
Sector 2
State/Province
Bucuresti
ZIP/Postal Code
022328
Country
Romania
Facility Name
Institutul Nat. de Boli Infectioase /ID# 163488
City
Bucuresti
ZIP/Postal Code
010825
Country
Romania
Facility Name
LLC Medical Company Hepatolog /ID# 161998
City
Samara
State/Province
Samarskaya Oblast
ZIP/Postal Code
443063
Country
Russian Federation
Facility Name
CBSI Central scientific and research institute of epidemiology /ID# 161996
City
Moscow
ZIP/Postal Code
105275
Country
Russian Federation
Facility Name
Central Clinical Hospital of R /ID# 163434
City
Moscow
ZIP/Postal Code
117593
Country
Russian Federation
Facility Name
Stavropol State Medical Univ /ID# 161999
City
Stavropol
ZIP/Postal Code
355017
Country
Russian Federation
Facility Name
RSAHI Consulting and Diagnostic Centre /ID# 161995
City
Tyumen
ZIP/Postal Code
625026
Country
Russian Federation
Facility Name
Hospital Parc de Salut del Mar /ID# 162198
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Univ Vall d'Hebron /ID# 162199
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario Reina S /ID# 162200
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital Donostia /ID# 162197
City
Donostia
ZIP/Postal Code
20080
Country
Spain
Facility Name
Hospital Univ Central Asturias /ID# 162195
City
Oviedo
ZIP/Postal Code
33011
Country
Spain
Facility Name
China Medical University Hosp /ID# 162950
City
Taichung City
State/Province
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 162949
City
Kaohsiung
ZIP/Postal Code
80708
Country
Taiwan
Facility Name
Taipei Veterans General Hosp /ID# 162776
City
Taipei City
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Basildon University Hospital /ID# 162616
City
Basildon
State/Province
Essex
ZIP/Postal Code
SS16 5NL
Country
United Kingdom
Facility Name
The Royal Free Hospital /ID# 162614
City
London
State/Province
London, City Of
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
North Manchester General /ID# 163945
City
Crumpsall
ZIP/Postal Code
M8 5RB
Country
United Kingdom
Facility Name
Western General Hospital /ID# 162612
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Queens Medical Centre /ID# 162615
City
Nottinghamshire
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
National Hospital of Tropical Diseases /ID# 167974
City
Hanoi
ZIP/Postal Code
100000
Country
Vietnam
Facility Name
Hoa Hao Medic Co. Ltd. /ID# 168178
City
Ho Chi Minh
ZIP/Postal Code
700000
Country
Vietnam
Facility Name
Tropical Diseases Hospital /ID# 168211
City
Ho Chi Minh
ZIP/Postal Code
700000
Country
Vietnam

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
IPD Sharing URL
https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Citations:
PubMed Identifier
31682879
Citation
Brown RS Jr, Buti M, Rodrigues L, Chulanov V, Chuang WL, Aguilar H, Horvath G, Zuckerman E, Carrion BR, Rodriguez-Perez F, Urbanek P, Abergel A, Cohen E, Lovell SS, Schnell G, Lin CW, Zha J, Wang S, Trinh R, Mensa FJ, Burroughs M, Felizarta F. Glecaprevir/pibrentasvir for 8 weeks in treatment-naive patients with chronic HCV genotypes 1-6 and compensated cirrhosis: The EXPEDITION-8 trial. J Hepatol. 2020 Mar;72(3):441-449. doi: 10.1016/j.jhep.2019.10.020. Epub 2019 Nov 2.
Results Reference
derived

Learn more about this trial

A Study of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment-Naive Adults With Chronic Hepatitis C Virus (HCV) Genotype 1-6 Infection and Compensated Cirrhosis

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