An interventional study of Alisporivir and Ribavirin in Hepatitis C and Liver Disease, sponsored by Debiopharm International SA. Completed at 25 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-20.
Sponsored by Debiopharm International SA · Not applicable, Interventional, and Treatment
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.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 147 is above the median of 100 across 1,886 interventional studies indexed under Hepatitis A.
Browse Hepatitis A studies →Debiopharm International SA is the lead sponsor of 50 studies on the registry; 6 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Human immunodeficiency virus (HIV) positive.
-
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).
Drug: Alisporivir · Drug: Ribavirin · Drug: Peg-IFNα2a
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).
Drug: Alisporivir · Drug: Ribavirin · Drug: Peg-IFNα2a
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).
Drug: Alisporivir · Drug: Ribavirin · Drug: Peg-IFNα2a
Alisporivir 100 mg or 200 mg soft gel capsules (SGC) in blister packs for oral administration
Also known as: DEB025
Ribavirin tablets of various strengths for oral administration
Also known as: RBV
Peg-IFNα2a solution for subcutaneous injection
Viral load drop from baseline through Week 12
Time frame: Baseline through Week 12
Percentage of participants who developed confirmed Stage II or greater hypertension (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg
Time frame: within 12 weeks
Change in platelet count from baseline through Week 12.
Time frame: Baseline through Week 12
Number of participants with Sustained Virologic Response at Week 12 follow-up (SVR12)
Time frame: 12 weeks after the end of treatment
This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Debiopharm International SA