AzTrials
AzTrials

Hepatitis C, ChronicPhase 4NCT00493805

Study of Response in Chronic Hepatitis C (CHC) Participants Genotype 1 With Insulin Resistance and Prolonged Treatment Duration in Late Responders (P04823/MK-4031-303)

A Phase 4 study testing Combination of pegylated interferon alfa-2b and ribavirin in people with Hepatitis C, Chronic and Insulin Resistance, run by Merck Sharp & Dohme LLC.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This is a Phase 3b/4, prospective, open-label, randomized, multicenter study of peginterferon alfa-2b plus ribavirin in participants with chronic hepatitis C, genotype 1. The study consists of two parts: (1) a noninterventional arm (HOMA IR <= 2) and (2) an interventional arm (HOMA IR > 2), where HOMA IR is the… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Hepatitis C, Chronic, Insulin Resistance
What is being tested?
Combination of pegylated interferon alfa-2b and ribavirin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
No sites listed yet
Study dates
Apr 2007to Oct 2009
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • male and female participants with newly diagnosed chronic hepatitis C
  • age 18-65
  • HCV-RNA positive in serum as measured by PCR
  • Genotype 1
  • ALT levels according to European labeling
  • in women of child-bearing age, pregnancy must be excluded prior to entry into the study, and the use of a safe contraceptive device must be documented; sexually active male participants must practice a method of contraception considered acceptable (vasectomy, condom plus spermicide, plus relationship with a female partner who practices an acceptable method of contraception)
Show all 16Show fewer
  • Lab parameters:
  • Hb: >=12 g/dL (women) or >= 13 g/dL (men)
  • leukocytes >= 3,000/µL
  • thrombocytes >= 100,000/µL
  • PT/PTT/coagulation must be within normal limits or clinically acceptable to the investigator/sponsor
  • Albumin must be within normal limits or clinically acceptable to the investigator/sponsor
  • creatinine must be within normal limits or clinically acceptable to the investigator/sponsor
  • uric acid must be within normal limits or clinically acceptable to the investigator/sponsor
  • antinuclear antibodies <= 1:160
  • signed informed consent

Who cannot join

  • refusal by women of child-bearing age or by sexually active participants to use a safe contraceptive
  • breast-feeding women
  • cirrhosis stage B and C according to Child-Pugh
  • signs of decompensated liver disease
  • confirmed co-infection with HIV or HBV
  • existing psychiatric comorbidity
Show all 14Show fewer
  • alcohol abuse
  • active malignant disease or suspicion or history of malignant disease within 5 previous years (except for adequately treated basal cell carcinoma)
  • existing psoriasis or other dermatological disorder
  • treatment with a study drug within the last 30 days
  • any uncontrolled underlying medical conditions
  • clinically significant ECG abnormalities and/or significant cardiovascular dysfunction within the last 6 months. In case of other suspected heart disease, a cardiological examination is required.
  • any liver disorder of other genesis than the study indication (with regard to elevated iron levels, only participants with manifest hemochromatosis are excluded)
  • autoimmune disorder (except LKM-positive participants).

About this study

Official title: Study to Evaluate Response Rates in Chronic Hepatitis C (CHC) Patients Genotype 1 With Insulin Resistance and to Assess Prolonged Treatment Duration in Late Virological Responders

This is a Phase 3b/4, prospective, open-label, randomized, multicenter study of peginterferon alfa-2b plus ribavirin in participants with chronic hepatitis C, genotype 1. The study consists of two parts: (1) a noninterventional arm (HOMA IR <= 2) and (2) an interventional arm (HOMA IR > 2), where HOMA IR is the insulin resistance index for the participants calculated by fasting insulin (uU/mL) x [fasting glucose (mmol/L)/22.5]. Participants in the noninterventional arm are treated according to the European labeling and response rates are evaluated at Month 1 (optional), 3, 6, 12, and follow up. Participants in the interventional arm are treated with PEG-Intron 1.5 ug/kg (subcutaneous) once weekly plus weight-based REBETOL 800-1400 mg (oral capsules) daily for a variable period depending on their response at Week 12: (1) HCV-RNA positive with < 2-log drop in viral load, treatment will be discontinued; (2) HCV-RNA positive with >= 2-log drop in viral load; participants will be randomized (1:1) to Group A (stop treatment at Week 48) or Group B (stop treatment at Week 72); and (3) HCV-RNA negative, treatment will be changed to be according to the European labeling and response rates will be evaluated at Month 6, 12, and follow up. All participants will go on with their treatment after Week 12 until the results of the HCV polymerase chain reaction (PCR) are available (maximum of 4 weeks).

Being tested
Combination of pegylated interferon alfa-2b and ribavirin
Keywords
homeostasis model assessment of insulin resistance
Medical subject headings
Hepatitis C, Chronic, Insulin Resistance

What participants receive

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

  • Combination of pegylated interferon alfa-2b and ribavirinDrug

    Also called (a) SCH 54031, PEG-Intron, (b) SCH 18908, Rebetol

    1. Powder for injection in Redipen (50, 80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for 12 weeks, then up to 4 weeks until HCV PCR results are available, and then for another 36 weeks(Group A) or 60 weeks (Group B) postrandomization.
    2. 200 mg capsules, oral, weight based dose of 800-1400 mg, daily for up to 12 weeks, then up to 4 weeks until HCV PCR results are available, and then for another 36 weeks (Group A) or 60 weeks (Group B) postrandomization

  • Combination of pegylated interferon alfa-2b and ribavirinDrug

    Also called (a) SCH 54031, PEG-Intron, (b) SCH 18908, Rebetol

    1. Powder for injection in Redipen (50, 80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for 48 weeks
    2. 200 mg capsules, oral, weight based dose of 800-1400 mg, daily for 48 weeks
Study groups in NCT00493805
Study groupRoleWhat they receive
Interventional Study arm (with insulin resistance)ExperimentalHOMA IR (homeostasis model assessment-estimated insulin resistance) of > 2 These participants received PEG-Intron 1.5 μg /kg subcutaneously (SC) once weekly plus weight based Rebetol 800-1400 mg by mouth (PO) administered twice daily (BID) for a variable period depending on their response to treatment.
Receives: Drug: Combination of pegylated interferon alfa-2b and ribavirin
Non interventional study arm (without insulin resistance)ExperimentalHOMA IR <= 2 These participants received PEG-Intron 1.5 μg /kg subcutaneously (SC) once weekly plus weight based Rebetol 800-1400 mg PO administered twice daily (BID) for 48 weeks. (Participants are treated according to European labeling).
Receives: Drug: Combination of pegylated interferon alfa-2b and ribavirin

What is being measured

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

  1. Early Virological Response in Participants With and Without Insulin Resistance

    Early Virological Response (EVR) defined as HCV PCR at Week 12 either negative or at least 2 log units less than baseline in participants with and without insulin resistance.

    Measured: At Week 12 (after start of therapy)

Secondary outcomes (1)

  1. Sustained Virological Response (PCR 24 Weeks After End of Treatment)

    Sustained virological response (SVR) was defined as undetectable HCV RNA in serum at the end of follow-up (24 weeks after end of therapy) according to a polymerase chain reaction (PCR) assay.

    Measured: Up to 24 weeks following 48 or 72 weeks of therapy

Timeline

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

  1. First posted28 Jun 2007 (estimated)
  2. Study startApr 2007
  3. Primary completionOct 2009
  4. Study completionOct 2009

Why it stopped: Slow Enrollment

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00493805
Sponsor's protocol ID
P04823
Other IDs
EudraCT number:2006-000757-21
Status last verified
Mar 2017
First submitted
25 Jun 2007
Last updated
7 Apr 2017
Data monitoring committee
No
Individual data sharing
Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Combination of pegylated interferon alfa-2b and ribavirin in people with Hepatitis C, Chronic and Insulin Resistance, run by Merck Sharp & Dohme LLC.

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 16 inclusion and 14 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: stopped early, as of the sponsor's last update on 7 Apr 2017. 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 9 Feb 2011). 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?

Early Virological Response in Participants With and Without Insulin Resistance (time frame: At Week 12 (after start of therapy)). 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 NCT00493805.

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 7 Apr 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in