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A study on optimizing Pegasys or Recombinant Human Interferon a-2b plus Ribavirin in treatment of na?ve patients with chronic hepatitis C.

Study on Prevention and Treatment of virus hepatitis

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-10001090
Enrollment
Unknown
Registered
2010-11-16
Start date
2010-01-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

chronic hepatitis C

Interventions

A:The subjects will be treated as follows: Pegasys 180ug/wk plus Ribavirin 10.6-15mg/kg/day for 44 weeks after HCV RNA undetectable/clearance
BA:The rest patients will be treated as follows: IFNa-2b 500MU/2 days plus Ribavirin 10.6-15mg/kg/day for 44 weeks after HCV RNA undetectable /clearance

Sponsors

Third Hospital of HeiBei Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Baseline examinations are consistent with the diagnosis of CHC; 2. Compensated liver diseases

Exclusion criteria

Exclusion criteria: 1. History or other evidence of decompensated liver disease (Coagulopathy, hyperbilirubinemia, hepatic encephalopathy, hypo-albuminemia, ascites, and bleeding from esophageal varices are conditons consistant with decompensated liver disease; patients with cirrhosis in Child-Pugh score > 6); 2. Co-infection with active hepatitis B, hepatitis D and/or human immuno- deficiency virus (HIV); 3. Neutrophil count 100 ng/mL; 6. Pregnant or breast-feeding females (positive pregnancy test immediately prior to initiation of therapy), male partners of women who are to be pregnant; 7. Serum creatinine level > 1.5 ULN at screening; 8. History of drug allergy on IFN or any compound of IFN; 9. History of drug and alcohol abuse; 10. History of autoimmune disease; History of severe psychiatric disease, especially depression; History of thyroid disease poorly controlled on prescribed medications; History of severe retinal disease; History of malignant tumor; History of chronic pulmonary disease with insufficient function; History of severe cardiac or digestive disease; History of disease aggravating anaemia; 11. Other issues that investigators consider unsuitable for this trial.

Design outcomes

Primary

MeasureTime frame
Sustained Virological Response (SVR);

Secondary

MeasureTime frame
Virological Response, Prognosis, Break-through and Relapse;Predictive factors for therapy efficacy;

Countries

China

Contacts

Public ContactYuemin Nan
nanyuemin@163.com+86 311 66781226

Outcome results

None listed

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