Hepatitis C, Liver Disease Clinical Trial
— ALtitude IIOfficial 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.
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 patients who have previously failed interferon therapy or are intolerant or unable to take interferon
| Status | Completed |
| Enrollment | 52 |
| Est. completion date | April 2015 |
| Est. primary completion date | April 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: 1. Written informed consent must be obtained before any assessment is performed. 2. HCV G2/3 patients who have previously failed interferon therapy or are intolerant or unable to take interferon. 3. Males or females aged =18 years. 4. Chronic hepatitis C virus infection diagnosed. 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. HBsAg positive 4. HIV positive. Other protocol-defined inclusion/exclusion criteria apply. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | Novartis Investigative Site | Clichy | |
| France | Novartis Investigative Site | Creteil | |
| France | Novartis Investigative Site | Lyon Cedex 04 | |
| France | Novartis Investigative Site | Nice Cedex 3 | |
| France | Novartis Investigative Site | Paris | |
| United States | Novartis Investigative Site | Arlington | Texas |
| United States | Novartis Investigative Site | Bakersfield | California |
| United States | Novartis Investigative Site | Houston | Texas |
| United States | Novartis Investigative Site | Lancaster | California |
| United States | Novartis Investigative Site | Newport News | Virginia |
| United States | Novartis Investigative Site | San Antonio | Texas |
| United States | Novartis Investigative Site | San Diego | California |
| United States | Novartis Investigative Site | San Diego | California |
| United States | Novartis Investigative Site | Seattle | Washington |
| United States | Novartis Investigative Site | Seattle | Washington |
| United States | Novartis Investigative Site | St. Louis | Missouri |
| Lead Sponsor | Collaborator |
|---|---|
| Debiopharm International SA |
United States, France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Difference in the level of Heptatis C virus decrease | Difference in the level of Heptatis C virus decrease between 2 treatment arms | 12 weeks | No |
| Primary | Difference in number of subjects with adverse events or with abnormal lab values | Difference in number of subjects with adverse events or with abnormal lab values between 2 treatment arms | 12 weeks | Yes |
| Primary | Pharmacokinetic | Difference in the level of study medication in the blood exposures (Cmax (ng/mL) and AUC (ng.h/mL)) between the 2 treatment arms | 12 weeks | No |
| Secondary | Sustained Virologic Response (SVR) 12 | number of participants who maintain undetectable Heptatis C virus 12 weeks after end of treatment between 2 treatment arms | 12 weeks of end of study treatment | No |