Evaluation of Unipeg® for Response and Ongoing Safety in Pakistani Population

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Hepatitis C is a global problem, prevalent in developed as well as in the developing countries. New treatment regimens using PegInterferon in combination with ribavirin has led to improved sustained viral response rates for some genotypes. A single arm, open labeled, multicentre trial was conducted to evaluate the response rate and safety of PegInterferon alfa-2a (Unipeg®) plus ribavirin (Ribazole®) for the treatment of patients with chronic hepatitis C infection. RVR at 4 weeks, ETR at 24 weeks for genotype 3 and at 48 weeks for genotype 1 patients and SVR was determined at 24 weeks after completion of treatment. Quality of life at baseline and at follow-up visits were determined using SF-36.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Getz Pharma
• Collaborator: Dimension Research
• Treatments: Interferon-alpha; Peginterferon alfa-2a; Ribavirin

Criteria

Inclusion Criteria:

1. Written Informed consent

2. Treatment naïve patients

3. Serological evidence of hepatitis C infection by an anti-HCV antibody test

4. HCV positive by PCR

5. Genotype 1,2 and 3

6. BMI 20-28

7. Participants were the resident of city where he /she enrolled at their respective centre

8. No evidence of liver cirrhosis

9. No other significant hepatic or systemic disease

10. No evidence of hepatic encephalopathy

11. Normal thyroid functions (By testing TSH)

12. Adequate bone marrow, liver and renal functions test

• Hematology: ANC≥1,000/mm3, Platelet count ≥100,000 mm3, Hemoglobin≥11.0g/dl in female and ≥ 12.0 g/dl in male

• Blood Chemistry: Total Bilirubin≤2.0mg/dl, AST and ALT <3 times normal

• Creatinine Clearance >50 ml/min

• Proteinuria: ≤ 0.5 g per 24h.

• Prothrombin Time or partial-thromboplastin time if ≤1.5 times the upper limit of the normal range.

Exclusion Criteria:

1. Unable to give consent

2. Prior treatment for Hepatitis C

3. Co-infection with HBV and HCV

4. Obesity

5. Iron overload

6. Other Genotypes e.g. 4, 5, 6 with their sub-types

7. Pregnant and lactating women

8. History of medical condition associated with chronic liver disease other than CHC (e.g. hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposure)

9. Uncontrolled Hypertension

10. Uncontrolled Diabetes

11. Severe Depression

12. Clinically significant cardio-vascular disease

13. Symptomatic peripheral vascular disease

14. Oral or parenteral anticoagulants or anti platelet agents

15. History of systemic anti-viral therapy at least three months prior to first dose of study medication