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

Hepatitis C Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02601976
• Other study ID #: GETZ-UNIP- 4010810
• Status: Completed
• Phase: Phase 4
• Start date: August 2010
• Est. completion date: September 2014

Study information

• Verified date: August 2018
• Source: Getz Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: September 2014
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Getz Pharma	Dimension Research

References & Publications (7)

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. — View 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

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. Review. — View 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. Review. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With Rapid Virological Response (RVR)	To evaluate the Rapid Virological Response (RVR) of all patients treated with PegInterferon Alfa-2a plus Ribavirin at 4 weeks of treatment	4 weeks
Other	Mean of Physical Component Score & Mental Component Score to Determine Quality of Life	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
Primary	Number of Participants With Sustained Virological Response (SVR)	To determine the SVR at 24 weeks after completion of treatment, among those who achieved ETR	Post treatment Week 24
Primary	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	Upto 48 weeks
Secondary	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	Upto 48 weeks