Clinical trial NCT02094443: Alisporivir With RBV in Chronic Hepatitis C Genotype 2 and 3 Participants for Whom Interferon is Not an Option
Official title: A Multicenter, Open-label, Randomized, 2-arm, Phase II Trial of Pharmacodynamics, Pharmacokinetics and Safety of Two Dose Regimens of DEB025/Alisporivir in Combination With Ribavirin Therapy in Chronic Hepatitis C Genotype 2 and 3 Patients Who Have Previously Failed Interferon Therapy or Are Intolerant or Unable to Take Interferon.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C
Liver Disease
Keywords: Chronic hepatitis C genotype 2
Chronic hepatitis C genotype 3
Cyclophilin inhibitor
Interferon intolerant
Lead sponsor: Debiopharm International SA
Sponsor class: INDUSTRY
First posted: 2014-03-21
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to evaluate the pharmacodynamic (i.e. hepatitis C virus (HCV) viral load), pharmacokinetic and safety profiles between two treatment groups receiving different doses of DEB025 in combination with ribavirin (RBV) during the first 12 weeks treatment in chronic hepatitis C genotype (GT)-2 and GT-3 patients who had previously failed interferon therapy or were intolerant or unable to take interferon.


Eligibility criteria: Inclusion Criteria:

1. Written informed consent must be obtained before any assessment is performed
2. Participants with HCV genotype 2 or 3 infection who have previously failed interferon therapy or are intolerant or unable to take interferon
3. Males or females aged ≥18 years
4. Diagnosed Chronic hepatitis C virus infection

Exclusion criteria:

1. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of that medication before enrollment
2. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
3. Hepatitis B surface antigen (HBsAg) positive
4. Human immunodeficiency virus (HIV) positive

Other protocol-defined inclusion/exclusion criteria apply.

Primary outcomes:
measure: Change From Baseline in Hepatitis C Virus Ribonucleic Acid Viral Load at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Alanine Aminotransferase (ALT) at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Percentage of Participants Achieving Sustained Virologic Response (SVR) 4, 12, and 24 Weeks After Treatment
timeFrame: Up to 24 weeks posttreatment
measure: Percentage of Participants With Extended Rapid Virologic Response
timeFrame: 2 weeks
measure: Percentage of Participants With Rapid Virologic Response (RVR)
timeFrame: 4 weeks
measure: Percentage of Participants With End of Treatment Response (ETR)
timeFrame: Up to 24 weeks
measure: Percentage of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Had Normalized ALT at Treatment End and Study End
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Novartis Investigative Site
state: California
city: Lancaster
country: United States
facility: Novartis Investigative Site
state: California
city: San Diego
country: United States
facility: Novartis Investigative Site
state: California
city: San Diego
country: United States
facility: Novartis Investigative Site
state: California
city: St. Louis
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Arlington
country: United States
facility: Novartis Investigative Site
state: Texas
city: Houston
country: United States
facility: Novartis Investigative Site
state: Texas
city: San Antonio
country: United States
facility: Novartis Investigative Site
state: Texas
city: Newport News
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Seattle
country: United States
facility: Novartis Investigative Site
state: Washington
city: Seattle
country: United States
facility: Novartis Investigative Site
state: Washington
city: Clichy
country: France
facility: Novartis Investigative Site
city: Creteil
country: France
facility: Novartis Investigative Site
city: Lyon Cedex 04
country: France
facility: Novartis Investigative Site
city: Nice Cedex 3
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: