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AzTrials

Hepatitis CPhase 4EUROPNCT02601976

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

A Phase 4 study testing Peginterferon alfa-2a and Ribavirin in people with Hepatitis C, run by Getz Pharma.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Hepatitis C
What is being tested?
Peginterferon alfa-2a and Ribavirin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
No sites listed yet
Study dates
Aug 2010to Sep 2014
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
Show all 17Show fewer
  • 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.

Who cannot join

  • 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
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  • 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

About this study

Official title: 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.

Read the 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.

Conditions
Hepatitis C
Being tested
Peginterferon alfa-2a, Ribavirin
Keywords
PegInterferon alpha-2a, Ribavirin, Hepatitis C Virus, Sustained Virological Response, End of Treatment Response, Unipeg, Ribazole
Medical subject headings
Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Peginterferon alfa-2aDrug

    Also called Unipeg

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

  • RibavirinDrug

    Also called Ribazole

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

Study groups in NCT02601976
Study groupRoleWhat they receive
PegInterferon alfa-2a and RibavirinExperimentalPegInterferon alfa-2a subcutaneously once weekly Ribavirin administered orally according to the body weight
Receives: Drug: Peginterferon alfa-2a; Drug: Ribavirin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Sustained Virological Response (SVR)

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

    Measured: Post treatment Week 24

  2. 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

    Measured: Upto 48 weeks

Secondary outcomes (1)

  1. 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

    Measured: Upto 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Nov 2015 (estimated)
  2. Study startAug 2010
  3. Primary completionSep 2012
  4. Study completionSep 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02601976
Sponsor's protocol ID
GETZ-UNIP- 4010810
Acronym
EUROP
Status last verified
Aug 2018
First submitted
2 Nov 2015
Last updated
27 Sep 2018
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 12407587

  • 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.

    PubMed 19323090

  • 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.

    PubMed 18835208

  • 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.

    PubMed 25911336

  • 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.

    PubMed 18498666

  • 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.

    PubMed 14996676

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Peginterferon alfa-2a and Ribavirin in people with Hepatitis C, run by Getz Pharma.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Sustained Virological Response (SVR) (time frame: Post treatment Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02601976, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2018.

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