Randomized Controlled Open Label Trial of Peg Alpha 2a Interferon and Adjusted-dose of Ribavirin vs. Standard Therapy in the Treatment of Naive Chronic Hepatitis C Patients Infected With Genotype 4

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The study aims to study the outcome of pharmacokinetics-adjusted dose ribavirin (plus pegIFN) on the SVR in chronic HCV patients.

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

Details

• Lead Sponsor: King Abdulaziz Medical City
• Treatments: Interferon alpha-2; Interferon-alpha; Interferons; Peginterferon alfa-2a; Ribavirin

Criteria

Inclusion Criteria:

1. 18-70 years of age

2. Chronic hepatitis C documented by a detectable HCV RNA level by a PCR performed within 3 months -A liver biopsy performed within 3 years or fibro test/fibroscan within 1 year of inclusion.

3. Naive patients

4. Genotype 4

5. Compensated cirrhosis hepatitis C liver disease (Child-Pugh ≤ 6)

6. Patient needing, according to the physician, the initiation of a combined therapy of pegylated interferon alfa plus Ribavirin

7. Negative HBsAg test and HIV-Elisa test

8. Negative pregnancy test at baseline in women in age of procreation

9. Efficient contraception all along the treatment period, and for 6 months after discontinuation of the treatment for women and men

Exclusion Criteria:

1. Decompensated Cirrhotic patients

2. HBV or HIV co-infection

3. Evidence of hepatocellular carcinoma

4. Significant and evolutive cardiovascular, pulmonary, severe psychiatric disorder or renal dysfunction (calculated creatinine CL < 50 ml/min) *. Patients who met the trial criteria if subsequent calculated creatinine CL < 50 ml/min may need ribavirin dose reduction.

5. Non compensated thyroid dysfunction

6. Recent history of epilepsy (less than 6 months)

7. Absolute contraindications to one of the drug of combination therapy

8. Any non-compensated cardiac disease including ischemic heart disease Chronic cardiac failure (grade III or IV - NYHA classification)

9. Uncontrolled high blood pressure (SBP > 180 mmHg during inclusion in spite of hypertension treatment)

10. Pregnancy or breast feeding.

11. Post liver transplantation patient with HCV

12. Alcohol or drug induced liver disease.

13. Metabolic or autoimmune liver disease.

14. Hemoglobinopathies or anemia; hemoglobin <12 gm /dl for females and <12.5 for males not corrected by erythropoietin

15. Neutropenia (<1500/mm³)

16. Thrombocytopenia (<90,000/mm3), thrombocytosis (> 500,000/mm3)

17. Patients with evolutive diabetic or hypertensive retinopathy. Patients who are stable can be included but should be regularly followed during treatment.

18. Hypersensitivity to epoetin beta or one of its excipients

19. Previous history or increased risk of venous thrombosis