Back to resultsEfficacy and Safety of 8-weeks of Glecaprevir/Pibrentasvir in Treatment-Naïve Adults With HCV Genotype 1-6 and Aspartate Aminotransferase to Platelet Ratio Index (APRI) ≤1
Primary Purpose
Hepatitis C Virus (HCV)
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Glecaprevir/Pibrentasvir
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C Virus (HCV) focused on measuring chronic hepatitis C virus (HCV), Hepatitis, HCV genotype, aspartate aminotransferase, platelet, Aspartate aminotransferase to Platelet Ratio Index (APRI), glecaprevir, pibrentasvir, Sustained Virologic Response 12 weeks post dosing (SVR12)
Eligibility Criteria
Inclusion Criteria:
- Hepatitis C virus (HCV) genotype (GT) 1, 2, 3, 4, 5, or 6 infection. Mixed GT and indeterminate GT may be acceptable.
- Aspartate aminotransferase (AST) to platelet ratio index (APRI) score of less than or equal to 1, at time of screening.
Does not have current active hepatitis B virus infection defined as:
- positive hepatitis B surface antigen (HBsAg), OR
- hepatitis B virus (HBV) deoxyribonucleic acid (DNA) > lower limit of quantification (LLOQ) in subjects with isolated positive anti-hepatitis B core (HBc) (i.e., negative HBsAg and anti-hepatitis B surface[HBs])
- Platelets ≥ 150,000 cells/mm³
- Albumin ≥ lower limit of normal (LLN)
- Positive anti-HCV antibody (Ab) AND plasma HCV ribonucleic acid (RNA) viral load ≥ 1,000 IU/mL at Screening and for at least 6 months before Screening.
- No past history/evidence of cirrhosis.
- No history of hepatocellular carcinoma.
- Hepatitis C virus treatment-naïve (had not received a single dose of any approved or investigational anti-HCV medication).
- If female, the subject must not be pregnant, breastfeeding, or considering becoming pregnant during the study and for 30 days after the last dose of study drug.
Sites / Locations
- Parkway Medical Center /ID# 161261
- Arkansas Gastroenterology /ID# 161266
- UC Davis Medical Center /ID# 161138
- Yale University /ID# 161258
- Univ Maryland School Medicine /ID# 161157
- Digestive Disease Associates - Baltimore /ID# 161260
- University of Michigan Hospitals /ID# 161265
- Northwest Gastroenterology Cli /ID# 161257
- Liver Associates of Texas, P.A /ID# 161262
- University of Vermont Medical Center /ID# 161263
- Digestive and Liver Disease Sp /ID# 161259
- DCC Aleksandrovska /ID# 161340
- DCC Mladost M /ID# 161339
- South Health Campus /ID# 161385
- The Moncton Hospital /ID# 161384
- Brampton Civic Hospital /ID# 161380
- Toronto Liver Centre /ID# 161381
- Hopital Saint Joseph /ID# 161571
- CHU de Rennes - PONTCHAILLOU /ID# 161492
- CHU de Besancon - Jean Minjoz /ID# 161485
- Hopitaux de Brabois Adultes /ID# 161482
- Universitätsklinikum Frankfurt /ID# 161397
- Universitaetsmedizin der Johannes-Gutenberg Universität Mainz /ID# 161396
- Charité Universitätsmedizin Campus Mitte /ID# 161395
- ICH Study Center GmbH & Co KG /ID# 161394
- Centrum Badan Klinicznych /Id# 162218
- HepID - Diagnostyka I Terapia /ID# 162219
- Uniwersytecki Szpital Kliniczn /ID# 162216
- ID Clinic /ID# 162217
- Innovative Care P.S.C. /ID# 162787
- A. F. Agafonov Republican Clin /ID# 163164
- South Ural State Medical univ /ID# 163163
- A.I. Evdokimov Moscow State Un /ID# 163162
- Hospital Fundacion Alcorcon /ID# 161436
- Hospital Clinic de Barcelona /ID# 161437
- Hospital Vall d'Hebron /ID# 162022
- Hosp Uni Virgen de la Victoria /ID# 164383
- Complexo Hospitalario universi /ID# 165603
- Bradford Teaching Hospitals /ID# 161424
- Glasgow Royal Infirmary /ID# 161458
- Gloucester Royal Hospital /ID# 161423
- Freeman Hospital /ID# 161459
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Glecaprevir/Pibrentasvir
Arm Description
Participants received oral glecaprevir/pibrentasvir (300 mg/120 mg) once daily with food for 8 weeks.
Outcomes
Primary Outcome Measures
Percentage of Participants in the Modified Intention-to-Treat Population With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ; 15 IU/mL) 12 weeks after the last dose of study drug.
The 95% confidence interval (95%CI) was calculated using the Wilson's score method.
Efficacy was to be established if the lower bound of the 95%CI was greater than the threshold of 92.4%, based on the historical rate observed in glecaprevir/pibrentasvir registrational studies in treatment-naïve, non-cirrhotic patients (98.4%) minus a margin of 6%.
Secondary Outcome Measures
Percentage of Participants in the Intention-to-Treat Population With SVR12
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the LLOQ (15 IU/mL) 12 weeks after the last dose of study drug.
The 95% confidence interval was calculated using the normal approximation to the binomial distribution. Efficacy was to be established if the lower bound of the 95%CI was greater than the threshold of 91.4%, based on the mITT threshold minus an expected 1% rate of non-virological SVR failures.
Percentage of Participants With On-treatment Virologic Failure
On-treatment virologic failure was defined as one of the following conditions:
confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < 15 IU/mL during the Treatment Period; or
confirmed increase from nadir in HCV RNA (two consecutive HCV RNA measurements > 1 log₁₀ IU/mL above nadir) at any time point during the Treatment Period; or
HCV RNA ≥ 15 IU/mL at end of treatment with at least 6 weeks of treatment, where the HCV RNA value must be collected on or after Study Drug Day 36 and study drug duration ≥ 36 days.
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 with HCV RNA levels < LLOQ at the end of treatment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03212521
Brief Title
Efficacy and Safety of 8-weeks of Glecaprevir/Pibrentasvir in Treatment-Naïve Adults With HCV Genotype 1-6 and Aspartate Aminotransferase to Platelet Ratio Index (APRI) ≤1
Official Title
A Single Arm, Open Label, Multicenter Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment Naïve Adults With Chronic Hepatitis C Virus (HCV) Genotypes 1 - 6 Infection and Aspartate Aminotransferase to Platelet Ratio Index (APRI) ≤ 1
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
August 7, 2017 (Actual)
Primary Completion Date
August 13, 2018 (Actual)
Study Completion Date
August 13, 2018 (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
Data Monitoring Committee
No
5. Study Description
Brief Summary
A study to evaluate the efficacy and safety of glecaprevir(GLE)/pibrentasvir(PIB) in treatment-naïve participants with chronic hepatitis C virus (HCV) genotypes 1-6 infection and with an aspartate aminotransferase to platelet ratio index (APRI) of less than or equal to 1.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C Virus (HCV)
Keywords
chronic hepatitis C virus (HCV), Hepatitis, HCV genotype, aspartate aminotransferase, platelet, Aspartate aminotransferase to Platelet Ratio Index (APRI), glecaprevir, pibrentasvir, Sustained Virologic Response 12 weeks post dosing (SVR12)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
230 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Glecaprevir/Pibrentasvir
Arm Type
Experimental
Arm Description
Participants received oral glecaprevir/pibrentasvir (300 mg/120 mg) once daily with food for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Glecaprevir/Pibrentasvir
Other Intervention Name(s)
ABT-493/ABT-530, MAVYRET™
Intervention Description
Glecaprevir/pibrentasvir 100 mg/40 mg co-formulated tablets taken orally as 3 tablets once a day.
Primary Outcome Measure Information:
Title
Percentage of Participants in the Modified Intention-to-Treat Population With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
Description
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ; 15 IU/mL) 12 weeks after the last dose of study drug.
The 95% confidence interval (95%CI) was calculated using the Wilson's score method.
Efficacy was to be established if the lower bound of the 95%CI was greater than the threshold of 92.4%, based on the historical rate observed in glecaprevir/pibrentasvir registrational studies in treatment-naïve, non-cirrhotic patients (98.4%) minus a margin of 6%.
Time Frame
12 weeks after the last actual dose of study drug, Week 20
Secondary Outcome Measure Information:
Title
Percentage of Participants in the Intention-to-Treat Population With SVR12
Description
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the LLOQ (15 IU/mL) 12 weeks after the last dose of study drug.
The 95% confidence interval was calculated using the normal approximation to the binomial distribution. Efficacy was to be established if the lower bound of the 95%CI was greater than the threshold of 91.4%, based on the mITT threshold minus an expected 1% rate of non-virological SVR failures.
Time Frame
12 weeks after the last actual dose of study drug, Week 20
Title
Percentage of Participants With On-treatment Virologic Failure
Description
On-treatment virologic failure was defined as one of the following conditions:
confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < 15 IU/mL during the Treatment Period; or
confirmed increase from nadir in HCV RNA (two consecutive HCV RNA measurements > 1 log₁₀ IU/mL above nadir) at any time point during the Treatment Period; or
HCV RNA ≥ 15 IU/mL at end of treatment with at least 6 weeks of treatment, where the HCV RNA value must be collected on or after Study Drug Day 36 and study drug duration ≥ 36 days.
Time Frame
Up to 8 weeks
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 with HCV RNA levels < LLOQ at the end of treatment.
Time Frame
From the end of treatment (Week 8) through 12 weeks after the last dose of study drug (Week 20)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hepatitis C virus (HCV) genotype (GT) 1, 2, 3, 4, 5, or 6 infection. Mixed GT and indeterminate GT may be acceptable.
Aspartate aminotransferase (AST) to platelet ratio index (APRI) score of less than or equal to 1, at time of screening.
Does not have current active hepatitis B virus infection defined as:
positive hepatitis B surface antigen (HBsAg), OR
hepatitis B virus (HBV) deoxyribonucleic acid (DNA) > lower limit of quantification (LLOQ) in subjects with isolated positive anti-hepatitis B core (HBc) (i.e., negative HBsAg and anti-hepatitis B surface[HBs])
Platelets ≥ 150,000 cells/mm³
Albumin ≥ lower limit of normal (LLN)
Positive anti-HCV antibody (Ab) AND plasma HCV ribonucleic acid (RNA) viral load ≥ 1,000 IU/mL at Screening and for at least 6 months before Screening.
No past history/evidence of cirrhosis.
No history of hepatocellular carcinoma.
Hepatitis C virus treatment-naïve (had not received a single dose of any approved or investigational anti-HCV medication).
If female, the subject must not be pregnant, breastfeeding, or considering becoming pregnant during the study and for 30 days after the last dose of study drug.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AbbVie Inc.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Parkway Medical Center /ID# 161261
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35215
Country
United States
Facility Name
Arkansas Gastroenterology /ID# 161266
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Facility Name
UC Davis Medical Center /ID# 161138
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Yale University /ID# 161258
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Univ Maryland School Medicine /ID# 161157
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Digestive Disease Associates - Baltimore /ID# 161260
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Facility Name
University of Michigan Hospitals /ID# 161265
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-5008
Country
United States
Facility Name
Northwest Gastroenterology Cli /ID# 161257
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Liver Associates of Texas, P.A /ID# 161262
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-2783
Country
United States
Facility Name
University of Vermont Medical Center /ID# 161263
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401-1473
Country
United States
Facility Name
Digestive and Liver Disease Sp /ID# 161259
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
DCC Aleksandrovska /ID# 161340
City
София
State/Province
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
DCC Mladost M /ID# 161339
City
Varna
ZIP/Postal Code
9000
Country
Bulgaria
Facility Name
South Health Campus /ID# 161385
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3M 1M4
Country
Canada
Facility Name
The Moncton Hospital /ID# 161384
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 6Z8
Country
Canada
Facility Name
Brampton Civic Hospital /ID# 161380
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6R 3J7
Country
Canada
Facility Name
Toronto Liver Centre /ID# 161381
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6H 3M1
Country
Canada
Facility Name
Hopital Saint Joseph /ID# 161571
City
Marseille CEDEX 08
State/Province
Bouches-du-Rhone
ZIP/Postal Code
13285
Country
France
Facility Name
CHU de Rennes - PONTCHAILLOU /ID# 161492
City
Rennes
State/Province
Bretagne
ZIP/Postal Code
35000
Country
France
Facility Name
CHU de Besancon - Jean Minjoz /ID# 161485
City
Besancon
State/Province
Doubs
ZIP/Postal Code
25000
Country
France
Facility Name
Hopitaux de Brabois Adultes /ID# 161482
City
Vandoeuvre les Nancy
State/Province
Lorraine
ZIP/Postal Code
54500
Country
France
Facility Name
Universitätsklinikum Frankfurt /ID# 161397
City
Frankfurt am Main
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Facility Name
Universitaetsmedizin der Johannes-Gutenberg Universität Mainz /ID# 161396
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Charité Universitätsmedizin Campus Mitte /ID# 161395
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
ICH Study Center GmbH & Co KG /ID# 161394
City
Hamburg
ZIP/Postal Code
20146
Country
Germany
Facility Name
Centrum Badan Klinicznych /Id# 162218
City
Wrocław
State/Province
Dolnoslaskie
ZIP/Postal Code
50-349
Country
Poland
Facility Name
HepID - Diagnostyka I Terapia /ID# 162219
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-884
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczn /ID# 162216
City
Bialystok
ZIP/Postal Code
15-276
Country
Poland
Facility Name
ID Clinic /ID# 162217
City
Myslowice
ZIP/Postal Code
41-406
Country
Poland
Facility Name
Innovative Care P.S.C. /ID# 162787
City
San Juan
ZIP/Postal Code
00959
Country
Puerto Rico
Facility Name
A. F. Agafonov Republican Clin /ID# 163164
City
Kazan
State/Province
Tatarstan, Respublika
ZIP/Postal Code
420140
Country
Russian Federation
Facility Name
South Ural State Medical univ /ID# 163163
City
Chelyabinsk
ZIP/Postal Code
454052
Country
Russian Federation
Facility Name
A.I. Evdokimov Moscow State Un /ID# 163162
City
Moscow
ZIP/Postal Code
127473
Country
Russian Federation
Facility Name
Hospital Fundacion Alcorcon /ID# 161436
City
Alcorcon
ZIP/Postal Code
28922
Country
Spain
Facility Name
Hospital Clinic de Barcelona /ID# 161437
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Vall d'Hebron /ID# 162022
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Facility Name
Hosp Uni Virgen de la Victoria /ID# 164383
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Complexo Hospitalario universi /ID# 165603
City
Pontevedra
ZIP/Postal Code
36071
Country
Spain
Facility Name
Bradford Teaching Hospitals /ID# 161424
City
Bradford
ZIP/Postal Code
BD9 6RJ
Country
United Kingdom
Facility Name
Glasgow Royal Infirmary /ID# 161458
City
Glasgow
ZIP/Postal Code
G4 0SF
Country
United Kingdom
Facility Name
Gloucester Royal Hospital /ID# 161423
City
Gloucester
ZIP/Postal Code
GL1 3NN
Country
United Kingdom
Facility Name
Freeman Hospital /ID# 161459
City
Newcastle Upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
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
31646465
Citation
Fontana RJ, Lens S, McPherson S, Elkhashab M, Ankoma-Sey V, Bondin M, Dos Santos AGP, Xue Z, Trinh R, Porcalla A, Zeuzem S. Efficacy and Safety of 8 Weeks of Glecaprevir/Pibrentasvir in Treatment-Naive, HCV-Infected Patients with APRI </= 1 in a Single-Arm, Open-Label, Multicenter Study. Adv Ther. 2019 Dec;36(12):3458-3470. doi: 10.1007/s12325-019-01123-0. Epub 2019 Oct 23.
Results Reference
derived
Learn more about this trial
Efficacy and Safety of 8-weeks of Glecaprevir/Pibrentasvir in Treatment-Naïve Adults With HCV Genotype 1-6 and Aspartate Aminotransferase to Platelet Ratio Index (APRI) ≤1
We'll reach out to this number within 24 hrs