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

Phase 4

Completed

• Conditions: Hepatitis C
• Interventions: Drug: Peginterferon alfa-2a; Drug: Ribavirin

• Registration Number: NCT02601976
• Lead Sponsor: Getz Pharma

Brief 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.

Detailed Description

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 Timeline

• Study Start: 2010-08
• Primary Completion: 2012-09
• Study Completion: 2014-09
• Study First Submitted: 2015-11-02
• Study First Submitted QC: 2015-11-09
• Study First Posted: 2015-11-11
• Status Verified: 2018-08
• Results First Submitted: 2018-08-01
• Results First Submitted QC: 2018-08-30
• Last Update Submitted: 2018-08-30
• Results First Posted: 2018-09-27
• Last Update Posted: 2018-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PegInterferon alfa-2a and Ribavirin	Ribavirin	PegInterferon alfa-2a subcutaneously once weekly Ribavirin administered orally according to the body weight
PegInterferon alfa-2a and Ribavirin	Peginterferon alfa-2a	PegInterferon alfa-2a subcutaneously once weekly Ribavirin administered orally according to the body weight

Primary Outcome Measures

Name	Time	Method
Number of Participants With End Treatment Response	Upto 48 weeks	To determine the End Treatment Response (ETR) rate of all patients treated with PegInterferon alfa-2a plus Ribavirin
Number of Participants With Sustained Virological Response (SVR)	Post treatment Week 24	To determine the SVR at 24 weeks after completion of treatment, among those who achieved ETR

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Reported Adverse Events	Upto 48 weeks	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