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

Primary Purpose

Hepatitis C

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Peginterferon alfa-2a

Ribavirin

About this trial

This is an interventional treatment trial for Hepatitis C focused on measuring PegInterferon alpha-2a, Ribavirin, Hepatitis C Virus, Sustained Virological Response, End of Treatment Response, Unipeg, Ribazole

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Written Informed consent
Treatment naïve patients
Serological evidence of hepatitis C infection by an anti-HCV antibody test
HCV positive by PCR
Genotype 1,2 and 3
BMI 20-28
Participants were the resident of city where he /she enrolled at their respective centre
No evidence of liver cirrhosis
No other significant hepatic or systemic disease
No evidence of hepatic encephalopathy
Normal thyroid functions (By testing TSH)
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:

Unable to give consent
Prior treatment for Hepatitis C
Co-infection with HBV and HCV
Obesity
Iron overload
Other Genotypes e.g. 4, 5, 6 with their sub-types
Pregnant and lactating women
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)
Uncontrolled Hypertension
Uncontrolled Diabetes
Severe Depression
Clinically significant cardio-vascular disease
Symptomatic peripheral vascular disease
Oral or parenteral anticoagulants or anti platelet agents
History of systemic anti-viral therapy at least three months prior to first dose of study medication

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PegInterferon alfa-2a and Ribavirin

Arm Description

PegInterferon alfa-2a subcutaneously once weekly Ribavirin administered orally according to the body weight

Outcomes

Primary Outcome Measures

Number of Participants With Sustained Virological Response (SVR)

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

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT02601976

First Posted

November 2, 2015

Last Updated

August 30, 2018

Sponsor

Getz Pharma

Collaborators

Dimension Research

1. Study Identification

Unique Protocol Identification Number

NCT02601976

Brief Title

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

Acronym

EUROP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

August 2010 (undefined)

Primary Completion Date

September 2012 (Actual)

Study Completion Date

September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Getz Pharma

Collaborators

Dimension Research

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis C

Keywords

PegInterferon alpha-2a, Ribavirin, Hepatitis C Virus, Sustained Virological Response, End of Treatment Response, Unipeg, Ribazole

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PegInterferon alfa-2a and Ribavirin

Arm Type

Experimental

Arm Description

PegInterferon alfa-2a subcutaneously once weekly Ribavirin administered orally according to the body weight

Intervention Type

Drug

Intervention Name(s)

Peginterferon alfa-2a

Other Intervention Name(s)

Unipeg

Intervention Description

PegInterferon alfa-2a 180mcg 20kDa administered subcutaneously once weekly for 24 weeks in genotype 3 and for 48 weeks in genotype 1 patients.

Intervention Type

Drug

Intervention Name(s)

Ribavirin

Other Intervention Name(s)

Ribazole

Intervention Description

Ribavirin administered orally in a divided daily dose according to body weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)

Primary Outcome Measure Information:

Title

Number of Participants With Sustained Virological Response (SVR)

Description

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

Time Frame

Post treatment Week 24

Title

Number of Participants With End Treatment Response

Description

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

Time Frame

Upto 48 weeks

Secondary Outcome Measure Information:

Title

Number of Participants Who Reported Adverse Events

Description

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

Time Frame

Upto 48 weeks

Other Pre-specified Outcome Measures:

Title

Number of Participants With Rapid Virological Response (RVR)

Description

To evaluate the Rapid Virological Response (RVR) of all patients treated with PegInterferon Alfa-2a plus Ribavirin at 4 weeks of treatment

Time Frame

4 weeks

Title

Mean of Physical Component Score & Mental Component Score to Determine Quality of Life

Description

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.

Time Frame

Upto 48 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Written Informed consent Treatment naïve patients Serological evidence of hepatitis C infection by an anti-HCV antibody test HCV positive by PCR Genotype 1,2 and 3 BMI 20-28 Participants were the resident of city where he /she enrolled at their respective centre No evidence of liver cirrhosis No other significant hepatic or systemic disease No evidence of hepatic encephalopathy Normal thyroid functions (By testing TSH) 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: Unable to give consent Prior treatment for Hepatitis C Co-infection with HBV and HCV Obesity Iron overload Other Genotypes e.g. 4, 5, 6 with their sub-types Pregnant and lactating women 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) Uncontrolled Hypertension Uncontrolled Diabetes Severe Depression Clinically significant cardio-vascular disease Symptomatic peripheral vascular disease Oral or parenteral anticoagulants or anti platelet agents History of systemic anti-viral therapy at least three months prior to first dose of study medication

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dr. Khawar Mehdi, MD

Organizational Affiliation

Getz Pharma Pakistan

Official's Role

Study Director

12. IPD Sharing Statement

Citations:

PubMed Identifier

12407587

Citation

Chander G, Sulkowski MS, Jenckes MW, Torbenson MS, Herlong HF, Bass EB, Gebo KA. Treatment of chronic hepatitis C: a systematic review. Hepatology. 2002 Nov;36(5 Suppl 1):S135-44. doi: 10.1053/jhep.2002.37146.

Results Reference

background

PubMed Identifier

19323090

Citation

Abbas Z, Jeswani NL, Kakepoto GN, Islam M, Mehdi K, Jafri W. Prevalence and mode of spread of hepatitis B and C in rural Sindh, Pakistan. Trop Gastroenterol. 2008 Oct-Dec;29(4):210-6.

Results Reference

background

PubMed Identifier

18835208

Citation

Ali SA, Donahue RM, Qureshi H, Vermund SH. Hepatitis B and hepatitis C in Pakistan: prevalence and risk factors. Int J Infect Dis. 2009 Jan;13(1):9-19. doi: 10.1016/j.ijid.2008.06.019. Epub 2008 Oct 2.

Results Reference

background

PubMed Identifier

25911336

Citation

European Association for Study of Liver. EASL Recommendations on Treatment of Hepatitis C 2015. J Hepatol. 2015 Jul;63(1):199-236. doi: 10.1016/j.jhep.2015.03.025. Epub 2015 Apr 21. No abstract available.

Results Reference

background

PubMed Identifier

18498666

Citation

Idrees M, Riazuddin S. Frequency distribution of hepatitis C virus genotypes in different geographical regions of Pakistan and their possible routes of transmission. BMC Infect Dis. 2008 May 23;8:69. doi: 10.1186/1471-2334-8-69.

Results Reference

background

PubMed Identifier

14996676

Citation

Hadziyannis SJ, Sette H Jr, Morgan TR, Balan V, Diago M, Marcellin P, Ramadori G, Bodenheimer H Jr, Bernstein D, Rizzetto M, Zeuzem S, Pockros PJ, Lin A, Ackrill AM; PEGASYS International Study Group. Peginterferon-alpha2a and ribavirin combination therapy in chronic hepatitis C: a randomized study of treatment duration and ribavirin dose. Ann Intern Med. 2004 Mar 2;140(5):346-55. doi: 10.7326/0003-4819-140-5-200403020-00010.

Results Reference

background

Citation

Ahmad, T., R. Ahsan, and G. Saba. Evaluation of Safety and Pharmacokinetic Behavior of Unipeg® in Healthy Human Volunteers. Journal of Pharmacy and Nutrition Sciences 2014;4.3:220-227

Results Reference

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

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