Back to resultsPharmacokinetics, Pharmacodynamics and Safety of DEB025 Plus Ribavirin in Chronic Hepatitis C Genotype 2 and 3 Treatment naïve Patients
Primary Purpose
Hepatitis C, Liver Disease
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Alisporivir
Ribavirin
Peg-IFNα2a
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C focused on measuring Chronic hepatitis C, DEB025, Alisporivir, ribavirin therapy, genotype 2/3 treatment naive patients
Eligibility Criteria
Inclusion Criteria:
- Written informed consent must be obtained before any assessment is performed.
- No previous treatment for Hepatitis C (HCV) infection (i.e. HCV treatment-naïve)
- Chronic hepatitis C (G2 or G3) virus infection diagnosed
Exclusion criteria:
- Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of that medication before enrollment.
- History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
- Hepatitis B Surface Antigen (HBsAg) positive
Human immunodeficiency virus (HIV) positive.
-
Sites / Locations
- 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
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
200 mg BID
300 mg BID
400 mg BID
Arm Description
Dual-therapy with a response-guided treatment duration with Alisporivir 200 mg twice daily (BID) and Ribavirin (RBV) for 12 or 24 weeks (Treatment period 1). Patients who were considered treatment failures were to be treated with peg-IFNα2a/RBV 800 mg daily for 24 weeks in Treatment period 2 (Roll-over treatment arm).
Dual-therapy with a response-guided treatment duration with Alisporivir 300mg BID and RBV for 12 or 24 weeks (Treatment period 1). Patients who were considered treatment failures were to be treated with peg-IFNα2a/RBV 800 mg daily for 24 weeks in Treatment period 2 (Roll-over treatment arm).
Dual-therapy with a response-guided treatment duration with Alisporivir 400 mg BID and RBV for 12 or 24 weeks (Treatment period 1). Patients who were considered treatment failures were to be treated with peg-IFNα2a/RBV 800 mg daily for 24 weeks in Treatment period 2 (Roll-over treatment arm).
Outcomes
Primary Outcome Measures
Viral load drop from baseline through Week 12
Percentage of participants who developed confirmed Stage II or greater hypertension (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg
Change in platelet count from baseline through Week 12.
Secondary Outcome Measures
Number of participants with Sustained Virologic Response at Week 12 follow-up (SVR12)
Full Information
NCT ID
NCT01970904
First Posted
September 30, 2013
Last Updated
April 18, 2016
Sponsor
Debiopharm International SA
1. Study Identification
Unique Protocol Identification Number
NCT01970904
Brief Title
Pharmacokinetics, Pharmacodynamics and Safety of DEB025 Plus Ribavirin in Chronic Hepatitis C Genotype 2 and 3 Treatment naïve Patients
Official Title
A Multicenter, Open-label, Randomized, 3-arm, Phase II Profiling Trial of Pharmacokinetics, Pharmacodynamics and Safety of DEB025/Alisporivir in Combination With Ribavirin Therapy in Chronic Hepatitis C Genotype 2 and 3 Treatment naïve Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (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
This study will explore the relationship of different DEB025 doses in combination with RBV to pharmacokinetic, pharmacodynamic (i.e. viral load reduction) and safety profiles in chronic hepatitis C GT 2 and 3 treatment naïve patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Liver Disease
Keywords
Chronic hepatitis C, DEB025, Alisporivir, ribavirin therapy, genotype 2/3 treatment naive patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
147 (Actual)
8. Arms, Groups, and Interventions
Arm Title
200 mg BID
Arm Type
Experimental
Arm Description
Dual-therapy with a response-guided treatment duration with Alisporivir 200 mg twice daily (BID) and Ribavirin (RBV) for 12 or 24 weeks (Treatment period 1). Patients who were considered treatment failures were to be treated with peg-IFNα2a/RBV 800 mg daily for 24 weeks in Treatment period 2 (Roll-over treatment arm).
Arm Title
300 mg BID
Arm Type
Experimental
Arm Description
Dual-therapy with a response-guided treatment duration with Alisporivir 300mg BID and RBV for 12 or 24 weeks (Treatment period 1). Patients who were considered treatment failures were to be treated with peg-IFNα2a/RBV 800 mg daily for 24 weeks in Treatment period 2 (Roll-over treatment arm).
Arm Title
400 mg BID
Arm Type
Experimental
Arm Description
Dual-therapy with a response-guided treatment duration with Alisporivir 400 mg BID and RBV for 12 or 24 weeks (Treatment period 1). Patients who were considered treatment failures were to be treated with peg-IFNα2a/RBV 800 mg daily for 24 weeks in Treatment period 2 (Roll-over treatment arm).
Intervention Type
Drug
Intervention Name(s)
Alisporivir
Other Intervention Name(s)
DEB025
Intervention Description
Alisporivir 100 mg or 200 mg soft gel capsules (SGC) in blister packs for oral administration
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Other Intervention Name(s)
RBV
Intervention Description
Ribavirin tablets of various strengths for oral administration
Intervention Type
Drug
Intervention Name(s)
Peg-IFNα2a
Intervention Description
Peg-IFNα2a solution for subcutaneous injection
Primary Outcome Measure Information:
Title
Viral load drop from baseline through Week 12
Time Frame
Baseline through Week 12
Title
Percentage of participants who developed confirmed Stage II or greater hypertension (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg
Time Frame
within 12 weeks
Title
Change in platelet count from baseline through Week 12.
Time Frame
Baseline through Week 12
Secondary Outcome Measure Information:
Title
Number of participants with Sustained Virologic Response at Week 12 follow-up (SVR12)
Time Frame
12 weeks after the end of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Written informed consent must be obtained before any assessment is performed.
No previous treatment for Hepatitis C (HCV) infection (i.e. HCV treatment-naïve)
Chronic hepatitis C (G2 or G3) virus infection diagnosed
Exclusion criteria:
Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of that medication before enrollment.
History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
Hepatitis B Surface Antigen (HBsAg) positive
Human immunodeficiency virus (HIV) positive.
-
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
Berlin
ZIP/Postal Code
10969
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Novartis Investigative Site
City
Duesseldorf
ZIP/Postal Code
40225
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
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Novartis Investigative Site
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Novartis Investigative Site
City
Kiel
ZIP/Postal Code
24146
Country
Germany
Facility Name
Novartis Investigative Site
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Novartis Investigative Site
City
Muenchen
ZIP/Postal Code
81377
Country
Germany
Facility Name
Novartis Investigative Site
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Novartis Investigative Site
City
Bialystok
ZIP/Postal Code
15-540
Country
Poland
Facility Name
Novartis Investigative Site
City
Lublin
ZIP/Postal Code
20-079
Country
Poland
Facility Name
Novartis Investigative Site
City
Warszawa
ZIP/Postal Code
01-201
Country
Poland
Facility Name
Novartis Investigative Site
City
Göteborg
ZIP/Postal Code
416 85
Country
Sweden
Facility Name
Novartis Investigative Site
City
Luleå
ZIP/Postal Code
SE-971 80
Country
Sweden
Facility Name
Novartis Investigative Site
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Novartis Investigative Site
City
Malmo
ZIP/Postal Code
SE-205 02
Country
Sweden
Facility Name
Novartis Investigative Site
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden
Facility Name
Novartis Investigative Site
City
Umea
ZIP/Postal Code
901 85
Country
Sweden
Facility Name
Novartis Investigative Site
City
Frimley
State/Province
Surrey
ZIP/Postal Code
GU16 7UJ
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Birmingham
ZIP/Postal Code
B15 2TT
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
12. IPD Sharing Statement
Learn more about this trial
Pharmacokinetics, Pharmacodynamics and Safety of DEB025 Plus Ribavirin in Chronic Hepatitis C Genotype 2 and 3 Treatment naïve Patients
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