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Efficacy and Safety of Adding Alisporivir (DEB025) to Peginterferon (IFN) Alfa-2a (Peg-IFN Alfa-2a) and Ribavirin in Chronic HCV Genotype 1 Patients Who Relapsed or Did Not Respond to Previous Treatment

Primary Purpose

Hepatitis C

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Alisporivir
Peginterferon alfa-2a
Ribavirin
Placebo
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, Cyclophilin inhibitor

Eligibility Criteria

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

Inclusion criteria:

  • Chronic HCV genotype 1 viral infection
  • HCV RNA ≥ 1,000 IU/ml assessed by quantitative polymerase chain reaction (qPCR) or equivalent at screening
  • Previous non-responders/relapsers to PEG and RBV after treatment for at least 12 weeks

Exclusion criteria:

  • Treatment with any anti-HCV drug (whether approved or investigational) within 3 months prior to screening
  • Women of child-bearing potential unless using highly effective
  • Any other cause of relevant liver disease other than HCV
  • Other protocol-defined inclusion/exclusion criteria may apply

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
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  • 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
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  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Treatment A: ALV 600 mg QD

Treatment B: ALV 800 mg QD

Treatment C1: ALV Placebo - 600 mg QD

Treatment C2: ALV Placebo - 400 mg BID

Treatment D: ALV 400 mg BID

Arm Description

Alisporivir (ALV) 600 mg once daily (QD) with Peginterferon alfa-2a (PEG) and Ribavirin (RBV) for up to 48 weeks

Alisporivir (ALV) 800 mg QD with PEG and RBV for up to 48 weeks

ALV Placebo with PEG and RBV for up to 48 weeks; participants not achieving complete early virologic response (cEVR) after 12 weeks of treatment may switch to active ALV 600 mg QD with PEG and RBV.

ALV Placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR after 12 weeks of treatment may switch to active ALV 400 mg twice daily (BID) with PEG and RBV.

Alisporivir (ALV) 400 mg twice daily BID with PEG and RBV for up to 48 weeks

Outcomes

Primary Outcome Measures

Percentage of Participants With Complete Early Viral Response Below the Limit of Quantification (cEVR-LOQ)
cEVR-LOQ was defined as serum HCV RNA below the limit of quantification (< LOQ; i.e., 25 IU/mL) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch.

Secondary Outcome Measures

Percentage of Participants With Complete Early Viral Response Below the Limit of Detection (cEVR-LOD)
cEVR-LOD was defined as serum HCV RNA below the limit of detection (< LOD; i.e., 10 IU/mL) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch.
Percentage of Participants Who Achieved Sustained Viral Response 12 Weeks After Treatment (SVR12)-LOQ and SVR12-LOD
SVR12-LOQ and SVR12-LOD were defined as serum HCV RNA < LOQ and serum HCV RNA < LOD 12 weeks after treatment, respectively.
Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After Treatment (SVR24)-LOQ and SVR24-LOD
SVR24-LOQ and SVR24-LOD were defined as serum HCV RNA < LOQ and serum HCV RNA < LOD 24 weeks after treatment, respectively.
Percentage of Participants With Rapid Viral Response (RVR)-LOQ and RVR-LOD
RVR-LOQ and RVR-LOD were defined as serum HCV RNA < LOQ and serum HCV RNA < LOD after 4 weeks of treatment, respectively. Post-switch groups were assessed 4 weeks after the switch.
Percentage of Participants With Partial Early Virologic Response After 12 Weeks of Treatment (pEVR)-LOQ and pEVR-LOD
pEVR-LOQ and pEVR-LOD were defined as a ≥ 2 log10 decrease in HCV RNA and still detectable (≥ LOQ and ≥ LOD, respectively) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch.
Percentage of Participants With End of Treatment Response (ETR)-LOQ and ETR-LOD
ETR-LOQ and ETR-LOD were defined as serum HCV RNA < LOQ and serum HCV RNA < LOD at treatment end (completed or prematurely discontinued), respectively.
Percentage of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Had Normalized ALT at Treatment End and Study End
Percentage of Participants With On-treatment Viral Breakthrough
On-treatment 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 (< LOQ) during treatment
Percentage of Participants With Viral Relapse
Viral relapse was defined as reappearance of detectable HCV RNA after previously being undetectable (< LOQ) during treatment.

Full Information

First Posted
August 16, 2010
Last Updated
July 14, 2016
Sponsor
Debiopharm International SA
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1. Study Identification

Unique Protocol Identification Number
NCT01183169
Brief Title
Efficacy and Safety of Adding Alisporivir (DEB025) to Peginterferon (IFN) Alfa-2a (Peg-IFN Alfa-2a) and Ribavirin in Chronic HCV Genotype 1 Patients Who Relapsed or Did Not Respond to Previous Treatment
Official Title
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase II Study on Efficacy and Safety of DEB025 Combined With Peg-IFN Alfa-2a and Ribavirin in Chronic Hepatitis C Genotype 1 Relapsers and Non-responders to Previous Peg-IFN Alfa-2 Plus Ribavirin Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study is to investigate whether participants with hepatitis C virus (HCV) genotype 1 who have a history of non-response/relapse to peginterferon alfa-2a (PEG) and ribavirin (RBV) may benefit from treatment with triple therapy alisporivir (ALV; DEB025) with PEG and RBV versus placebo with PEG and RBV.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
459 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment A: ALV 600 mg QD
Arm Type
Experimental
Arm Description
Alisporivir (ALV) 600 mg once daily (QD) with Peginterferon alfa-2a (PEG) and Ribavirin (RBV) for up to 48 weeks
Arm Title
Treatment B: ALV 800 mg QD
Arm Type
Experimental
Arm Description
Alisporivir (ALV) 800 mg QD with PEG and RBV for up to 48 weeks
Arm Title
Treatment C1: ALV Placebo - 600 mg QD
Arm Type
Experimental
Arm Description
ALV Placebo with PEG and RBV for up to 48 weeks; participants not achieving complete early virologic response (cEVR) after 12 weeks of treatment may switch to active ALV 600 mg QD with PEG and RBV.
Arm Title
Treatment C2: ALV Placebo - 400 mg BID
Arm Type
Experimental
Arm Description
ALV Placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR after 12 weeks of treatment may switch to active ALV 400 mg twice daily (BID) with PEG and RBV.
Arm Title
Treatment D: ALV 400 mg BID
Arm Type
Experimental
Arm Description
Alisporivir (ALV) 400 mg twice daily BID with PEG and RBV for up to 48 weeks
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 200 mg tablets (weight-based dose: < 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
ALV Placebo
Intervention Description
ALV placebo soft gel capsules administered orally
Primary Outcome Measure Information:
Title
Percentage of Participants With Complete Early Viral Response Below the Limit of Quantification (cEVR-LOQ)
Description
cEVR-LOQ was defined as serum HCV RNA below the limit of quantification (< LOQ; i.e., 25 IU/mL) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch.
Time Frame
after 12 weeks of treatment
Secondary Outcome Measure Information:
Title
Percentage of Participants With Complete Early Viral Response Below the Limit of Detection (cEVR-LOD)
Description
cEVR-LOD was defined as serum HCV RNA below the limit of detection (< LOD; i.e., 10 IU/mL) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch.
Time Frame
after 12 weeks of treatment
Title
Percentage of Participants Who Achieved Sustained Viral Response 12 Weeks After Treatment (SVR12)-LOQ and SVR12-LOD
Description
SVR12-LOQ and SVR12-LOD were defined as serum HCV RNA < LOQ and serum HCV RNA < LOD 12 weeks after treatment, respectively.
Time Frame
12 weeks after treatment
Title
Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After Treatment (SVR24)-LOQ and SVR24-LOD
Description
SVR24-LOQ and SVR24-LOD were defined as serum HCV RNA < LOQ and serum HCV RNA < LOD 24 weeks after treatment, respectively.
Time Frame
24 weeks after treatment
Title
Percentage of Participants With Rapid Viral Response (RVR)-LOQ and RVR-LOD
Description
RVR-LOQ and RVR-LOD were defined as serum HCV RNA < LOQ and serum HCV RNA < LOD after 4 weeks of treatment, respectively. Post-switch groups were assessed 4 weeks after the switch.
Time Frame
after 4 weeks of treatment
Title
Percentage of Participants With Partial Early Virologic Response After 12 Weeks of Treatment (pEVR)-LOQ and pEVR-LOD
Description
pEVR-LOQ and pEVR-LOD were defined as a ≥ 2 log10 decrease in HCV RNA and still detectable (≥ LOQ and ≥ LOD, respectively) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch.
Time Frame
after 12 weeks of treatment
Title
Percentage of Participants With End of Treatment Response (ETR)-LOQ and ETR-LOD
Description
ETR-LOQ and ETR-LOD were defined as serum HCV RNA < LOQ and serum HCV RNA < LOD at treatment end (completed or prematurely discontinued), respectively.
Time Frame
within 48 weeks
Title
Percentage of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Had Normalized ALT at Treatment End and Study End
Time Frame
Up to 48 weeks
Title
Percentage of Participants With On-treatment Viral Breakthrough
Description
On-treatment 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 (< LOQ) during treatment
Time Frame
within 48 weeks
Title
Percentage of Participants With Viral Relapse
Description
Viral relapse was defined as reappearance of detectable HCV RNA after previously being undetectable (< LOQ) during treatment.
Time Frame
within 24 weeks after 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 HCV genotype 1 viral infection HCV RNA ≥ 1,000 IU/ml assessed by quantitative polymerase chain reaction (qPCR) or equivalent at screening Previous non-responders/relapsers to PEG and RBV after treatment for at least 12 weeks Exclusion criteria: Treatment with any anti-HCV drug (whether approved or investigational) within 3 months prior to screening Women of child-bearing potential unless using highly effective Any other cause of relevant liver disease other than HCV Other protocol-defined inclusion/exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
San Diego
State/Province
California
ZIP/Postal Code
92101
Country
United States
Facility Name
Novartis Investigative Site
City
San Diego
State/Province
California
ZIP/Postal Code
92115
Country
United States
Facility Name
Novartis Investigative Site
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
Novartis Investigative Site
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34209
Country
United States
Facility Name
Novartis Investigative Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Novartis Investigative Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Novartis Investigative Site
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
Novartis Investigative Site
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
Novartis Investigative Site
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62703
Country
United States
Facility Name
Novartis Investigative Site
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Novartis Investigative Site
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
Facility Name
Novartis Investigative Site
City
Egg Harbor Twp
State/Province
New Jersey
ZIP/Postal Code
08234
Country
United States
Facility Name
Novartis Investigative Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11230
Country
United States
Facility Name
Novartis Investigative Site
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Novartis Investigative Site
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Novartis Investigative Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246-2096
Country
United States
Facility Name
Novartis Investigative Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Novartis Investigative Site
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 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
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Novartis Investigative Site
City
Nice Cedex 3
ZIP/Postal Code
06202
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
79106
Country
Germany
Facility Name
Novartis Investigative Site
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
Facility Name
Novartis Investigative Site
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Novartis Investigative Site
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Novartis Investigative Site
City
Bekescsaba
ZIP/Postal Code
H-5600
Country
Hungary
Facility Name
Novartis Investigative Site
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Novartis Investigative Site
City
Budapest
ZIP/Postal Code
1126
Country
Hungary
Facility Name
Novartis Investigative Site
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Novartis Investigative Site
City
Kaposvár
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Novartis Investigative Site
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Novartis Investigative Site
City
Antella - Bagno a Ripoli
State/Province
FI
ZIP/Postal Code
50012
Country
Italy
Facility Name
Novartis Investigative Site
City
Palermo
State/Province
PA
ZIP/Postal Code
90127
Country
Italy
Facility Name
Novartis Investigative Site
City
Padova
State/Province
PD
ZIP/Postal Code
35128
Country
Italy
Facility Name
Novartis Investigative Site
City
Parma
State/Province
PR
ZIP/Postal Code
43100
Country
Italy
Facility Name
Novartis Investigative Site
City
Roma
State/Province
RM
ZIP/Postal Code
00161
Country
Italy
Facility Name
Novartis Investigative Site
City
Bologna
ZIP/Postal Code
40138
Country
Italy
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
Warszawa
ZIP/Postal Code
01-201
Country
Poland
Facility Name
Novartis Investigative Site
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
Facility Name
Novartis Investigative Site
City
Bucharest
State/Province
District 1
ZIP/Postal Code
050526
Country
Romania
Facility Name
Novartis Investigative Site
City
Bucharest
State/Province
District 3
ZIP/Postal Code
030317
Country
Romania
Facility Name
Novartis Investigative Site
City
Bucharest
ZIP/Postal Code
020125
Country
Romania
Facility Name
Novartis Investigative Site
City
Bucharest
ZIP/Postal Code
021105
Country
Romania
Facility Name
Novartis Investigative Site
City
Iasi
ZIP/Postal Code
700506
Country
Romania
Facility Name
Novartis Investigative Site
City
Sevilla
State/Province
Andalucia
ZIP/Postal Code
41014
Country
Spain
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08003
Country
Spain
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08035
Country
Spain
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08036
Country
Spain
Facility Name
Novartis Investigative Site
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28029
Country
Spain
Facility Name
Novartis Investigative Site
City
Taipei
State/Province
Taiwan, ROC
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Keelung City
ZIP/Postal Code
20401
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Lin-Ko
ZIP/Postal Code
33305
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Niaosong Township
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Yun-Lin
ZIP/Postal Code
640
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Novartis Investigative Site
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Facility Name
Novartis Investigative Site
City
Fatih / Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Novartis Investigative Site
City
Izmir
ZIP/Postal Code
35040
Country
Turkey
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
NW3 2PR
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety of Adding Alisporivir (DEB025) to Peginterferon (IFN) Alfa-2a (Peg-IFN Alfa-2a) and Ribavirin in Chronic HCV Genotype 1 Patients Who Relapsed or Did Not Respond to Previous Treatment

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