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

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-IFNalpha2a Plus Ribavirin) in Treatment-naïve Hepatitis C Genotype 2 and 3 Patients. - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/002967

Enrollment

340

Registered

2010-12-29

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Hepatitis C Chronic

Interventions

Intervention1: DEB025: 600 milligram QD + RBV 400 milligram BID orally, for 52 weeks Intervention2: DEB025: 800 milligram QD + RBV 400 milligram BID Intervention3: DEB025: 1000 milligram QD Interventi

Eligibility

Inclusion criteria

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

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. 4. ALT greater than or equal to 10 times ULN. Other protocol-defined inclusion/exclusion criteria may apply

Design outcomes

Primary

Measure	Time frame
Measure: RVR : Rapid Viral Response : defined as serum HCV RNA undetectable (by LOQ) after 4 weeks of treatment.Timepoint: 4 weeks	—

Secondary

Measure	Time frame
Measure: SVR24 : Sustained Viral Response Week 24 : defined as serum HCV RNA undetectable (by LOD) after 24 weeks of treatment.Timepoint: 24 weeks	—

Countries

Australia, Belgium, Canada, France, Germany, India, Italy, Poland, Republic of Korea, Taiwan, Thailand, United Kingdom, United States of America

Contacts

Public ContactMurugananthan K

murugananthan.k@novartis.com02224958545

Outcome results

None listed

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

Efficacy and Safety of DEB025 Alone or Combined With Either Ribavirin or Peg-IFN &#945;2a in Chronic Hepatitis C Genotype 2 and 3 naïve Patients