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Efficacy and Safety of Alisporivir Alone or Combined With RBV or PEG in Chronic Hepatitis C Genotype 2 and 3 Treatment-naïve Participants

Primary Purpose

Hepatitis C, Chronic Pain

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Alisporivir
Peginterferon alfa-2a
Ribavirin
Sponsored by
Debiopharm International SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C focused on measuring Chronic hepatitis C genotype 2, Chronic hepatitis C genotype 3, Cyclophilin inhibitor

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • Chronic hepatitis C viral infection
  • Plasma HCV RNA level lower limit ≥ 10,000 IU/ml assessed by quantitative polymerase chain reaction (qPCR) or equivalent at screening (no upper limit)
  • HCV genotype 2 or 3
  • No previous treatment for hepatitis C infection

Exclusion criteria:

  • Evidence of cirrhosis at the time of screening
  • Evidence of hepatocellular carcinoma at the time of screening
  • Any other cause of relevant liver disease other than HCV
  • Alanine aminotransferase (ALT) ≥ 10 times upper limit of normal (ULN)
  • Other protocol-defined inclusion/exclusion criteria may apply

Sites / Locations

  • Scripps Clinic
  • Sharp Rees-Stealy Medical Group, Inc.
  • Research and Education Inc.
  • Island View Gastroenterology Associates
  • Hawai Medical Center East LLC
  • Cotton O'Neil Clinical Research
  • The Office of Dr. Claudia Martorell
  • Saint Louis University
  • Dartmouth-Hitchcock Medical Center
  • Weill Cornell Medical Center
  • Mount Sinai Medical Center
  • Columbia University Medical Center
  • The North Texas Research Institute
  • Liver Associates of Texas
  • Liver Specialist of Texas
  • Alamo Medical Research
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Center
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Inestigative Site
  • Novartis Investigative Site
  • Novartis Inestigative Center
  • Novartis Investigative Site
  • Novartis Korea Ltd.
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Fundacion de Investigacion de Diego
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

ALV 1000 mg

ALV 600 mg+RBV

ALV 800 mg+RBV

ALV 600 mg+PEG

PEG+RBV

Arm Description

Alisporivir (ALV) 600 mg twice daily (BID) for 1 week, followed by ALV 1000 mg once daily (QD) during Weeks 2 to 24.

Alisporivir (ALV) 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with ribavirin (RBV) during Weeks 2 to 24.

Alisporivir (ALV) 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.

Alisporivir (ALV) 600 mg BID with Peginterferon alfa-2a (PEG) for 1 week, followed by ALV 600 mg QD with PEG once weekly during Weeks 2 to 24.

Peginterferon alfa-2a (PEG) and RBV during Weeks 1 to 24.

Outcomes

Primary Outcome Measures

Percentage of Participants With Rapid Viral Response (RVR) After 4 Weeks of Treatment < the Limit of Quantification (RVR4LOQ)
RVR4LOQ was defined as RVR [serum hepatitis C virus (HCV) ribonucleic acid (RNA) < the limit of quantification (LOQ), i.e., < 25 IU/mL], after 4 weeks of treatment.

Secondary Outcome Measures

Percentage of Participants With RVR After 4 Weeks of Treatment < the Limit of Detection (RVR4LOD)
RVR4LOD was defined as Rapid Viral Response (RVR) [serum HCV RNA < the limit of detection (LOD), i.e., < 10 IU/mL], after 4 weeks of treatment.
Percentage of Participants With RVR4LOQ and RVR4LOD (Genotype 2)
Percentage of Participants With RVR4LOQ and RVR4LOD (Genotype 3)
Percentage of Participants With Complete Early Viral Response (cEVR) After 12 Weeks of Treatment (cEVR12LOQ and cEVR12LOD)
cEVR12LOQ and cEVR12LOD were defined as cEVR [serum HCV RNA < LOQ and < LOD] after 12 weeks of treatment, respectively.
Percentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 2)
Percentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 3)
Percentage of Participants With End of Treatment Response (ETR) Within 24 Weeks (ETR24LOQ and ETR24LOD)
ETR24LOQ and ETR24LOD were defined as ETR [serum HCV RNA < LOQ and < LOD] after 24 weeks of treatment or when prematurely discontinued.
Percentage of Participants With ETR24LOQ and ETR24LOD (Genotype 2)
Percentage of Participants With ETR24LOQ and ETR24LOD (Genotype 3)
Percentage of Participants With RVR Who Achieved Sustained Viral Response (SVR) 12 Weeks After the End of Treatment (SVR12LOQ and SVR12LOD)
SVR12LOQ and SVR12LOD were defined as Sustained Viral Response (SVR) [serum HCV RNA < LOQ and < LOD] 12 weeks after treatment, respectively.
Percentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 2)
Percentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 3)
Percentage of Participants With RVR Who Achieved SVR at 24 Weeks After the End of Treatment (SVR24LOQ and SVR24LOD)
Percentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 2)
Percentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 3)
Percentage of Participants With On-treatment Viral Breakthrough
Viral breakthrough was defined as either: Confirmed increase of HCV RNA ≥1 log10 above nadir (nadir = lowest HCV RNA value during treatment), or HCV RNA becoming ≥ 100 IU/mL after previously being undetectable (< LOD) during treatment
Percentage of Participants With Viral Relapse
Viral relapse was defined as having reappearance of detectable HCV RNA after previously being undetectable (< LOD) during treatment.

Full Information

First Posted
October 5, 2010
Last Updated
July 20, 2016
Sponsor
Debiopharm International SA
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1. Study Identification

Unique Protocol Identification Number
NCT01215643
Brief Title
Efficacy and Safety of Alisporivir Alone or Combined With RBV or PEG in Chronic Hepatitis C Genotype 2 and 3 Treatment-naïve Participants
Official Title
A Multicenter, Randomized, Open Label, Parallel-group Phase IIB Study on the Efficacy and Safety of Oral Regimens of DEB025 Alone or in Combination With Ribavirin Versus Standard of Care (Peg-IFNα2a Plus Ribavirin) in Treatment-naïve Hepatitis C Genotype 2 and 3 Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Debiopharm International SA

4. Oversight

5. Study Description

Brief Summary
The study is to investigate whether alisporivir (ALV; DEB025) alone or in combination with either ribavirin (RBV) or peginterferon alfa-2a (PEG) is more efficient compared to standard of care (PEG+RBV) in treatment-naïve participants with hepatitis C virus (HCV) genotype 2 and 3. In addition, triple therapy with DEB025 plus standard of care will be applied to participants not achieving rapid viral response (RVR) in the different arms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Chronic Pain
Keywords
Chronic hepatitis C genotype 2, Chronic hepatitis C genotype 3, Cyclophilin inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
340 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ALV 1000 mg
Arm Type
Experimental
Arm Description
Alisporivir (ALV) 600 mg twice daily (BID) for 1 week, followed by ALV 1000 mg once daily (QD) during Weeks 2 to 24.
Arm Title
ALV 600 mg+RBV
Arm Type
Experimental
Arm Description
Alisporivir (ALV) 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with ribavirin (RBV) during Weeks 2 to 24.
Arm Title
ALV 800 mg+RBV
Arm Type
Experimental
Arm Description
Alisporivir (ALV) 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
Arm Title
ALV 600 mg+PEG
Arm Type
Experimental
Arm Description
Alisporivir (ALV) 600 mg BID with Peginterferon alfa-2a (PEG) for 1 week, followed by ALV 600 mg QD with PEG once weekly during Weeks 2 to 24.
Arm Title
PEG+RBV
Arm Type
Active Comparator
Arm Description
Peginterferon alfa-2a (PEG) and RBV during Weeks 1 to 24.
Intervention Type
Drug
Intervention Name(s)
Alisporivir
Other Intervention Name(s)
DEB025, ALV
Intervention Description
ALV 200 mg soft gel capsules administered orally
Intervention Type
Drug
Intervention Name(s)
Peginterferon alfa-2a
Other Intervention Name(s)
Pegasys®, PEG
Intervention Description
PEG 180 μg administered via subcutaneous (s.c.) injection once weekly
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Other Intervention Name(s)
Copegus®, RBV
Intervention Description
RBV 400 mg (2 x 200 mg tablets) administered orally twice daily (BID)
Primary Outcome Measure Information:
Title
Percentage of Participants With Rapid Viral Response (RVR) After 4 Weeks of Treatment < the Limit of Quantification (RVR4LOQ)
Description
RVR4LOQ was defined as RVR [serum hepatitis C virus (HCV) ribonucleic acid (RNA) < the limit of quantification (LOQ), i.e., < 25 IU/mL], after 4 weeks of treatment.
Time Frame
after 4 weeks of treatment
Secondary Outcome Measure Information:
Title
Percentage of Participants With RVR After 4 Weeks of Treatment < the Limit of Detection (RVR4LOD)
Description
RVR4LOD was defined as Rapid Viral Response (RVR) [serum HCV RNA < the limit of detection (LOD), i.e., < 10 IU/mL], after 4 weeks of treatment.
Time Frame
after 4 weeks of treatment
Title
Percentage of Participants With RVR4LOQ and RVR4LOD (Genotype 2)
Time Frame
after 4 weeks of treatment
Title
Percentage of Participants With RVR4LOQ and RVR4LOD (Genotype 3)
Time Frame
after 4 weeks of treatment
Title
Percentage of Participants With Complete Early Viral Response (cEVR) After 12 Weeks of Treatment (cEVR12LOQ and cEVR12LOD)
Description
cEVR12LOQ and cEVR12LOD were defined as cEVR [serum HCV RNA < LOQ and < LOD] after 12 weeks of treatment, respectively.
Time Frame
after 12 weeks of treatment
Title
Percentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 2)
Time Frame
after 12 weeks of treatment
Title
Percentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 3)
Time Frame
after 12 weeks of treatment
Title
Percentage of Participants With End of Treatment Response (ETR) Within 24 Weeks (ETR24LOQ and ETR24LOD)
Description
ETR24LOQ and ETR24LOD were defined as ETR [serum HCV RNA < LOQ and < LOD] after 24 weeks of treatment or when prematurely discontinued.
Time Frame
at end of treatment, within 24 weeks
Title
Percentage of Participants With ETR24LOQ and ETR24LOD (Genotype 2)
Time Frame
at end of treatment, within 24 weeks
Title
Percentage of Participants With ETR24LOQ and ETR24LOD (Genotype 3)
Time Frame
at end of treatment, within 24 weeks
Title
Percentage of Participants With RVR Who Achieved Sustained Viral Response (SVR) 12 Weeks After the End of Treatment (SVR12LOQ and SVR12LOD)
Description
SVR12LOQ and SVR12LOD were defined as Sustained Viral Response (SVR) [serum HCV RNA < LOQ and < LOD] 12 weeks after treatment, respectively.
Time Frame
12 weeks after the end of treatment
Title
Percentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 2)
Time Frame
12 weeks after the end of treatment
Title
Percentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 3)
Time Frame
12 weeks after the end of treatment
Title
Percentage of Participants With RVR Who Achieved SVR at 24 Weeks After the End of Treatment (SVR24LOQ and SVR24LOD)
Time Frame
24 weeks after the end of treatment
Title
Percentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 2)
Time Frame
24 weeks after the end of treatment
Title
Percentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 3)
Time Frame
24 weeks after the end of treatment
Title
Percentage of Participants With On-treatment Viral Breakthrough
Description
Viral breakthrough was defined as either: Confirmed increase of HCV RNA ≥1 log10 above nadir (nadir = lowest HCV RNA value during treatment), or HCV RNA becoming ≥ 100 IU/mL after previously being undetectable (< LOD) during treatment
Time Frame
within 24 weeks of treatment
Title
Percentage of Participants With Viral Relapse
Description
Viral relapse was defined as having reappearance of detectable HCV RNA after previously being undetectable (< LOD) during treatment.
Time Frame
within 24 weeks after the end of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Chronic hepatitis C viral infection Plasma HCV RNA level lower limit ≥ 10,000 IU/ml assessed by quantitative polymerase chain reaction (qPCR) or equivalent at screening (no upper limit) HCV genotype 2 or 3 No previous treatment for hepatitis C infection Exclusion criteria: Evidence of cirrhosis at the time of screening Evidence of hepatocellular carcinoma at the time of screening Any other cause of relevant liver disease other than HCV Alanine aminotransferase (ALT) ≥ 10 times upper limit of normal (ULN) Other protocol-defined inclusion/exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Scripps Clinic
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Sharp Rees-Stealy Medical Group, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92101
Country
United States
Facility Name
Research and Education Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92105
Country
United States
Facility Name
Island View Gastroenterology Associates
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
Hawai Medical Center East LLC
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
Cotton O'Neil Clinical Research
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
The Office of Dr. Claudia Martorell
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
Facility Name
Saint Louis University
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756-0001
Country
United States
Facility Name
Weill Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
The North Texas Research Institute
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Liver Associates of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Liver Specialist of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Alamo Medical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Novartis Investigative Site
City
Kingswood
State/Province
New South Wales
ZIP/Postal Code
2747
Country
Australia
Facility Name
Novartis Investigative Site
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Novartis Investigative Site
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Novartis Investigative Center
City
Greenslopes
State/Province
Queensland
ZIP/Postal Code
4120
Country
Australia
Facility Name
Novartis Investigative Site
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Novartis Investigative Site
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Novartis Investigative Site
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Novartis Investigative Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Novartis Investigative Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Novartis Investigative Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1H2
Country
Canada
Facility Name
Novartis Investigative Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4V 1P7
Country
Canada
Facility Name
Novartis Investigative Site
City
Clichy Cedex
ZIP/Postal Code
92118
Country
France
Facility Name
Novartis Investigative Site
City
Creteil
ZIP/Postal Code
94000
Country
France
Facility Name
Novartis Investigative Site
City
Marseille
ZIP/Postal Code
13008
Country
France
Facility Name
Novartis Investigative Site
City
Paris
ZIP/Postal Code
75006
Country
France
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
10969
Country
Germany
Facility Name
Novartis Investigative Site
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Novartis Investigative Site
City
Freiburg
ZIP/Postal Code
79095
Country
Germany
Facility Name
Novartis Investigative Site
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Novartis Investigative Site
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Novartis Investigative Site
City
Trivandrum
State/Province
Kerala
ZIP/Postal Code
695607
Country
India
Facility Name
Novartis Investigative Site
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400036
Country
India
Facility Name
Novartis Investigative Site
City
Ludhiana
State/Province
Punjab
ZIP/Postal Code
141001
Country
India
Facility Name
Novartis Investigative Site
City
Lucknow
State/Province
Uttar Pradesh
ZIP/Postal Code
226014
Country
India
Facility Name
Novartis Investigative Site
City
Guwahati
ZIP/Postal Code
781006
Country
India
Facility Name
Novartis Investigative Site
City
Haryana
ZIP/Postal Code
122001
Country
India
Facility Name
Novartis Investigative Site
City
Hyderabad - Andhra Pradesh
ZIP/Postal Code
500012
Country
India
Facility Name
Novartis Investigative Site
City
Mumbai
ZIP/Postal Code
400020
Country
India
Facility Name
Novartis Investigative Site
City
New Delhi
ZIP/Postal Code
110070
Country
India
Facility Name
Novartis Investigative Site
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Novartis Investigative Site
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Novartis Investigative Site
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Novartis Inestigative Site
City
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
Novartis Investigative Site
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Novartis Inestigative Center
City
Pusan
ZIP/Postal Code
602-739
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Pusan
ZIP/Postal Code
614-735
Country
Korea, Republic of
Facility Name
Novartis Korea Ltd.
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
738-736
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Bialystok
ZIP/Postal Code
15-540
Country
Poland
Facility Name
Novartis Investigative Site
City
Lódz
ZIP/Postal Code
91-347
Country
Poland
Facility Name
Novartis Investigative Site
City
Warsaw
ZIP/Postal Code
01 - 201
Country
Poland
Facility Name
Fundacion de Investigacion de Diego
City
San Juan
ZIP/Postal Code
00927
Country
Puerto Rico
Facility Name
Novartis Investigative Site
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Niaosong Township
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Taipei
ZIP/Postal Code
ROC112
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Yun-Lin
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Novartis Investigative Site
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Novartis Investigative Site
City
Songkla
ZIP/Postal Code
90110
Country
Thailand
Facility Name
Novartis Investigative Site
City
Glasgow - Scotland
ZIP/Postal Code
G12 OYN
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Plymouth
ZIP/Postal Code
PL6 8DH
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
26118427
Citation
Pawlotsky JM, Flisiak R, Sarin SK, Rasenack J, Piratvisuth T, Chuang WL, Peng CY, Foster GR, Shah S, Wedemeyer H, Hezode C, Zhang W, Wong KA, Li B, Avila C, Naoumov NV; VITAL-1 study team. Alisporivir plus ribavirin, interferon free or in combination with pegylated interferon, for hepatitis C virus genotype 2 or 3 infection. Hepatology. 2015 Oct;62(4):1013-23. doi: 10.1002/hep.27960. Epub 2015 Aug 10.
Results Reference
result

Learn more about this trial

Efficacy and Safety of Alisporivir Alone or Combined With RBV or PEG in Chronic Hepatitis C Genotype 2 and 3 Treatment-naïve Participants

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