Pharmacokinetics, pharmacodynamics and safety of DEB025/Alisporivir in combination with ribavirin therapy in chronic hepatitis C genotype 2 and 3 treatment naive patients

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-004185-17-SE

Enrollment

150

Registered

2013-06-17

Start date

2013-08-15

Completion date

Unknown

Last updated

2015-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic hepatitis C MedDRA version: 14.1 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: Copegus Pharmaceutical Form: Tablet INN or Proposed INN: Ribavirin CAS Number: 36791-04-5 Other descriptive name: RIBAVIRIN Concentration unit: mg milligram(s) Concentration type: equal Co

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Written informed consent must be obtained before any assessment is performed. 2. No previous treatment for Hepatitis C infection (i.e. HCV treatment-naïve) 3. Chronic hepatitis C virus infection diagnosed Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 147 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3

Exclusion criteria

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. History of pancreatitis or history strongly suggestive of previous pancreatitis 4. HBsAg positive or HIV positive.

Design outcomes

Primary

Measure	Time frame
Main Objective: Pharmacodynamics, Pharmacokinetic, safety profiles between treatment groups receiving 3 different doses of DEB025 in combination with RBV;Secondary Objective: Evaluate the SVR12 among 3 treatment groups with different doses of DEB025 in combination with ribavirin in chronic heptatitis C GT2 and 3 treatment naive patients;Primary end point(s): •viral load drop from baseline through week 12 •changes in serum triglycerides from baseline through week 12 •proportion of patients who develop confirmed Stage II or greater hypertension (SBP =160 mm Hg or DBP =100 mm Hg). •changes in platelet count from baseline through week 12. ;Timepoint(s) of evaluation of this end point: treatment week 12	—

Measure

Time frame

Main Objective: Pharmacodynamics, Pharmacokinetic, safety profiles between treatment groups receiving 3 different doses of DEB025 in combination with RBV;Secondary Objective: Evaluate the SVR12 among 3 treatment groups with different doses of DEB025 in combination with ribavirin in chronic heptatitis C GT2 and 3 treatment naive patients;Primary end point(s): •viral load drop from baseline through week 12 •changes in serum triglycerides from baseline through week 12 •proportion of patients who develop confirmed Stage II or greater hypertension (SBP =160 mm Hg or DBP =100 mm Hg). •changes in platelet count from baseline through week 12. ;Timepoint(s) of evaluation of this end point: treatment week 12

—

Secondary

Measure	Time frame
Secondary end point(s): HCV RNA viral load SVR12;Timepoint(s) of evaluation of this end point: SVR 12	—

Countries

Germany, Poland, Sweden, United Kingdom

Contacts

Public ContactMedical information

Novartis Sverige AB

medinfo.se@novartis.com+4687323200

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026