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

Phase 4CompletedNCT02601976

Getz Pharma64 enrolled

Overview

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.

A multicenter, phase IV, open labeled, single arm study was conducted. Total 110 patients were screened for recruitment. Out of which 67 subjects met the inclusion criteria, 3 failed to give the informed consent and were excluded. The final sample size of the study was 64 patients. The duration of study was August 2010 to September 2013. Peginterferon alfa-2a 180µg 20kDa (Unipeg®) solution for injection was administered as single dose sub-cutaneous once weekly for 24 weeks to patients with genotype 3 and 48 weeks in patients with genotype 1 at the site of recruitment. Ribavirin (Ribazole) orally were given in divided daily dose according to body weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg). Quality of life related Physical Component Score (PCS) \& Mental Component Score (MCS) were measured through Health-Related Quality of Life (HRQOL) Questionnaire (SF-36). The SF-36 questionnaire was completed for all patients during their evaluations before treatment, at 4 weeks, at the end of treatment and at 24 weeks after completion of treatment.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of Participants With Sustained Virological Response (SVR)

To determine the SVR at 24 weeks after completion of treatment, among those who achieved ETR

Time frame: Post treatment Week 24

Number of Participants With End Treatment Response

To determine the End Treatment Response (ETR) rate of all patients treated with PegInterferon alfa-2a plus Ribavirin

Time frame: Upto 48 weeks

Secondary Outcomes

Number of Participants Who Reported Adverse Events

To determine the number of patients treated with PegInterferon Alfa-2a plus Ribavirin who experience any adverse drug reaction. All ADR are reported as per patient information leaflet