BIP48 (Peginterferon Alfa 2b 48kDa) Compared With Pegasys® (Peginterferon 2a 40kDa) for Treatment of Chronic Hepatitis C

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to demonstrate the noninferiority of BIP48 (48 kDa peginterferon alfa-2b) compared to Pegasys ® (40 kDa peginterferon alfa-2a) associated with ribavirin, in naive patients with chronic hepatitis C.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
• Collaborator: Hospital de Clinicas de Porto Alegre
• Treatments: Interferon-alpha; Peginterferon alfa-2a; Peginterferon alfa-2b

Criteria

Inclusion Criteria:

1. anti-HCV positive;

2. viral load of HCV positive;

3. viral genotypes 1, 2 or 3;

4. the absence of previous treatment for chronic hepatitis C;

5. liver biopsy performed in the last 36 months classified by Metavir score as at least A1, with any degree of fibrosis ;

6. age from 18 to 70 years old;

7. hemoglobin greater than 11 g / dl;

8. platelet count higher than 75.000/mm3;

9. neutrophils higher than 1.500/mm3;

10. use of, at least two contraceptive methods during treatment and up to 36 weeks after the last dose of study medication (for male or female subjects in fertile age );

11. concordance and signing of the informed consent.

Exclusion Criteria:

1. decompensated cirrhosis (Child-Pugh score> 6);

2. history of bleeding gastroesophageal varices;

3. hemoglobinopathies;

4. hepatocellular carcinoma;

5. co-infection with HIV or HBV;

6. other coexisting chronic liver disease, as autoimmune hepatitis, Wilson disease, hemochromatosis, chronic obstructive cholestatic disease or autoimmune disease, alcoholic liver disease;

7. malignancies except basal cell carcinoma in situ or cervix carcinoma;

8. systemic autoimmune diseases, except compensated autoimmune thyroid diseases ;

9. uncontrolled seizures;

10. primary immunodeficiencies;

11. myelosuppression;

12. coagulation disorders;

13. thrombophilias;

14. thrombopathy ;

15. decompensated heart failure;

16. chronic renal failure;

17. diagnosis of other comorbidity that would compromise the subject's participation in the research study as judged by the investigator (eg, neuropsychiatric diseases, systemic infection or antibiotic use within 4 weeks, decompensated diabetes mellitus, ischemic heart disease, heart failure, respiratory or renal or uncontrolled hypertension);

18. prior organ transplantation, except cornea;

19. alcohol consumption exceeding 20g/day for women and 40g/dia for men during the past six months;

20. use of illicit drugs in the previous six months;

21. use of immunosuppressive agents during the previous six months;

22. pregnancy or lactation;

23. male research subjects whose sexual partner is pregnant;

24. previous treatment with IFN or ribavirin in the last 6 months prior to inclusion;

25. subjects with hypersensibility to IFN alpha and / or any of its components;

26. subjects with hypersensibility to ribavirin and / or any of its ingredients;

27. participation in another clinical study in the last 12 months