Efficacy and Safety of DEB025 Alone or Combined With Either Ribavirin or Peg-IFN α2a in Chronic Hepatitis C Genotype 2 and 3 naïve Patients

Status:	Completed
Conditions:	Chronic Pain, Chronic Pain, Hepatitis
Therapuetic Areas:	Immunology / Infectious Diseases, Musculoskeletal
Healthy:	No
Age Range:	18 - 70
Updated:	4/21/2016
Start Date:	October 2010
End Date:	May 2012

A Multicenter, Randomized, Open Label, Parallel-group Phase IIB Study on the Efficacy and Safety of Oral Regimens of DEB025 Alone or in Combination With Ribavirin Versus Standard of Care (Peg-IFNα2a Plus Ribavirin) in Treatment-naïve Hepatitis C Genotype 2 and 3 Patients.

The study is to investigate whether DEB025 alone or in combination with either ribavirin or
peg-IFNα2a is more efficient compared to SOC in treatment-naïve patients with HCV genotype 2
and 3. In addition, triple therapy with DEB025 plus SOC will be applied to patients not
achieving RVR in the different arms.

Inclusion criteria:

- Chronic hepatitis C viral

- Plasma HCV RNA level lower limit ≥ 10000 IU/ml assessed by qPCR (quantitative
polymerase chain reaction) or equivalent at screening; no upper limit;

- HCV genotype 2 or 3;

- No previous treatment for Hepatitis C infection

Exclusion criteria:

- Patients with evidence of Cirrhosis at the time of screening.

- Patients with evidence of Hepatocellular carcinoma at the time of screening.

- Any other cause of relevant liver disease other than HCV.

- ALT ≥ 10 times ULN.

- Other protocol-defined inclusion/exclusion criteria may apply

We found this trial at

sites

Novartis Investigative Site

Kingswood, New South Wales 2747

7534

from 91732

Kingswood,