Pharmacokinetics, Pharmacodynamics and Safety of DEB025 Plus Ribavirin in Chronic Hepatitis C Genotype 2 and 3 Treatment naïve Patients

Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01970904
• Other study ID #: CDEB025A2222
• Secondary ID: 2012-004185-17
• Status: Completed
• Phase: N/A
• First received: September 30, 2013
• Last updated: April 18, 2016
• Start date: October 2013
• Est. completion date: March 2015

Study information

• Verified date: April 2016
• Source: Debiopharm International SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products AgencyGermany: Federal Institute for Drugs and Medical DevicesUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: March 2015
• Est. primary completion date: March 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. No previous treatment for Hepatitis C (HCV) infection (i.e. HCV treatment-naïve)

3. Chronic hepatitis C (G2 or G3) 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. Hepatitis B Surface Antigen (HBsAg) positive

4. Human immunodeficiency virus (HIV) positive.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Liver Disease
• Liver Diseases

Intervention

Drug:
• Alisporivir
Alisporivir 100 mg or 200 mg soft gel capsules (SGC) in blister packs for oral administration
• Ribavirin
Ribavirin tablets of various strengths for oral administration
• Peg-IFNa2a
Peg-IFNa2a solution for subcutaneous injection

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Duesseldorf
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Freiburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hannover
Germany	Novartis Investigative Site	Kiel
Germany	Novartis Investigative Site	Köln
Germany	Novartis Investigative Site	Muenchen
Germany	Novartis Investigative Site	Würzburg
Poland	Novartis Investigative Site	Bialystok
Poland	Novartis Investigative Site	Lublin
Poland	Novartis Investigative Site	Warszawa
Sweden	Novartis Investigative Site	Göteborg
Sweden	Novartis Investigative Site	Luleå
Sweden	Novartis Investigative Site	Lund
Sweden	Novartis Investigative Site	Malmo
Sweden	Novartis Investigative Site	Stockholm
Sweden	Novartis Investigative Site	Umea
United Kingdom	Novartis Investigative Site	Birmingham
United Kingdom	Novartis Investigative Site	Frimley	Surrey
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	London

Sponsors (1)

Lead Sponsor	Collaborator
Debiopharm International SA

Countries where clinical trial is conducted

Germany,  Poland,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Viral load drop from baseline through Week 12		Baseline through Week 12	No
Primary	Percentage of participants who developed confirmed Stage II or greater hypertension (SBP = 160 mmHg or DBP = 100 mmHg		within 12 weeks	No
Primary	Change in platelet count from baseline through Week 12.		Baseline through Week 12	No
Secondary	Number of participants with Sustained Virologic Response at Week 12 follow-up (SVR12)		12 weeks after the end of treatment	No