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

NCT02601976 | Completed Phase 4 Results DMC

• 1 other identifier: GETZ-UNIP- 4010810
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hepatitis C

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Number of Participants Who Reported Adverse Events

  Upto 48 weeks

Other Outcomes (2)

• Number of Participants With Rapid Virological Response (RVR)

  4 weeks

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

  Upto 48 weeks

Study Arms (1)

PegInterferon alfa-2a and Ribavirin

EXPERIMENTAL

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

Drug: Peginterferon alfa-2a; Drug: Ribavirin

Interventions

Peginterferon alfa-2a DRUG

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

Also known as: Unipeg

PegInterferon alfa-2a and Ribavirin

Ribavirin DRUG

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

Also known as: Ribazole

PegInterferon alfa-2a and Ribavirin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Getz Pharma: lead
• Dimension Research: collaborator

Related Publications (7)

• 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.

  PMID: 12407587 BACKGROUND

• 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.

  PMID: 19323090 BACKGROUND

• 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.

  PMID: 18835208 BACKGROUND

• 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.

  PMID: 25911336 BACKGROUND

• 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.

  PMID: 18498666 BACKGROUND

• 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.

  PMID: 14996676 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Hepatitis C

Interventions

peginterferon alfa-2a; Ribavirin; alpha-ribazole

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Mr. Jaffer Bin Baqar
• Organization: Getz Pharma

jaffer.baqar@getzpharma.com

111111511

Study Officials

• Dr. Khawar Mehdi, MD

  Getz Pharma Pakistan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2015
• First Posted: November 11, 2015
• Study Start: August 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2014
• Last Updated: September 27, 2018
• Results First Posted: September 27, 2018

Record last verified: 2018-08