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

August 30, 2018 updated by: Getz Pharma

Response Evaluation of Peginterferon Alfa-2a 180µg 20kDa (Unipeg®) Plus Ribavirin (Ribazole®) in Treatment naïve Pakistani Population With Chronic Hepatitis C Infection

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PegInterferon alfa-2a and Ribavirin
PegInterferon alfa-2a subcutaneously once weekly Ribavirin administered orally according to the body weight
Drug: Peginterferon alfa-2a
PegInterferon alfa-2a 180mcg 20kDa administered subcutaneously once weekly for 24 weeks in genotype 3 and for 48 weeks in genotype 1 patients.
Other Names:
  • Unipeg
Drug: Ribavirin
Ribavirin administered orally in a divided daily dose according to body weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
Other Names:
  • Ribazole

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Reported Adverse Events
Time Frame: 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
Upto 48 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Rapid Virological Response (RVR)
Time Frame: 4 weeks
To evaluate the Rapid Virological Response (RVR) of all patients treated with PegInterferon Alfa-2a plus Ribavirin at 4 weeks of treatment
4 weeks
Mean of Physical Component Score & Mental Component Score to Determine Quality of Life
Time Frame: Upto 48 weeks
To determine and compare the changes in quality of life (QOL) from baseline to end of the treatment. Health-Related Quality of Life (HRQOL) Questionnaire (SF-36) was used to measure the quality of life. The SF-36 is a widely used questionnaire, and consists of 36 questions measuring eight concepts: Physical Function (PF), Role Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Function (SF), Role Emotional (RE), and Mental Health (MH). The scoring of the SF-36 questionnaire in our study was conducted upon a 0-100 scale, with higher scores reflecting better health status.
Upto 48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Getz Pharma

Collaborators

Dimension Research

Investigators

  • Study Director: Dr. Khawar Mehdi, MD, Getz Pharma Pakistan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

November 2, 2015

First Submitted That Met QC Criteria

November 9, 2015

First Posted (Estimate)

November 11, 2015

Study Record Updates

Last Update Posted (Actual)

September 27, 2018

Last Update Submitted That Met QC Criteria

August 30, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GETZ-UNIP- 4010810

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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