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Hepatitis C, ChronicPhase 3NCT00302081

Three Regimens of PegIntron Plus Ribavirin in Previously Untreated Chronic Hepatitis C, Genotype 2 or 3 (Study P03548)

A Phase 3 study testing peginterferon alfa-2b (SCH 54031) and ribavirin (SCH 18908) in people with Hepatitis C, Chronic, run by Merck Sharp & Dohme LLC.

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

This is a randomized, open-label, multinational study designed to evaluate the "standard" regimen, PegIntron 1.5 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg daily [Arm PEG2b 1.5/R (24 weeks)], compared to a lower dose regimen, PegIntron 1.0 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Hepatitis C, Chronic
What is being tested?
peginterferon alfa-2b (SCH 54031) and ribavirin (SCH 18908)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
696 participants
Where
No sites listed yet
Study dates
Aug 2003to Apr 2008
Phase
Phase 3
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The subject must meet ALL of the criteria listed below for entry into the study:
  • Hemoglobin >= 11 g/dL (females); >= 12 g/dL (males)
  • Platelet count >= 100,000/mm^3
  • Neutrophil count >= 1,500/mm^3
  • Adult male or female chronic hepatitis C (CHC) patients (HCV-RNA-positive in serum) with compensated liver disease (Child-Pugh Score <7) and indication for treatment according on current consensus guidelines (1. NIH Consensus Conference on the Management of Hepatitis C, 2002; 2. German Consensus Conference on Hepatitis B and C, published in Z Gastro 2004; 42 (8): 677-730).
  • >= 18 to =< 70 years of age
Show all 18Show fewer
  • At least one abnormal ALT value in the last year
  • HCV genotype 2 or 3
  • Not previously treated with any interferon or ribavirin alone or in combination
  • TSH level must be within normal limits
  • At the Screen Visit, glucose must be 70-140 mg/dL. Results between 116-140 mg/dL require repeat fasting glucose to be less than140 mg/dL and HbA1C less than or equal to 8.5%. HbA1C must be less than or equal to 8.5% in diabetic subjects (whether on medication or diet controlled).
  • Female subjects cannot be pregnant or breastfeeding and must be either postmenopausal, surgically sterile or using 2 methods of birth control. While abstinence from sexual activity is the only certain method to prevent pregnancy, female patients of childbearing potential who are or who anticipate the possibility of becoming sexually active with a male partner must use a combination of the following 2 methods: (1)contraceptive pill or IUD or depot hormonal preparation (ring, injection implant); and (2) a barrier method of contraception such as diaphragm, sponge with spermicide, condom, or a method of birth control considered acceptable by the study physician. Contraceptive measures will be reviewed with female subjects at each visit. Dual methods of contraception must be used for 6 months after treatment discontinuation.
  • Sexually active male subjects must be practicing acceptable methods of contraception (vasectomy, use of condom plus spermicide, monogamous relationship with a female partner who practices an acceptable method of contraception) during the treatment period and for 7 months after stopping treatment
  • Subjects must be willing to give written informed consent and able to adhere to dosing and visit schedules.
  • Confirmation by the principal investigator or a sub-investigator that sexually active females of childbearing potential are practicing adequate contraception.
  • A serum pregnancy test obtained at Screen Visit prior to the initiation of treatment must be negative
  • Confirmation by the principal investigator or a sub-investigator that sexually active male subjects are practicing a method of contraception considered acceptable (vasectomy, condom plus spermicide, plus relationship with a female partner who practices an acceptable method of contraception). Contraception must be used during the treatment period and for seven months (or 6 months, according to local label) after the completion of therapy, including condom use by male subjects with pregnant partners.
  • For subjects with a history of hypertension or diabetes, written clearance from an ophthalmologist has to be obtained prior to treatment start

Who cannot join

  • Patients younger than 18 years
  • Patients older than 70 years of age.
  • Positive Anti-HIV antibodies
  • Positive HBsAg antibodies
  • Patients with severe renal dysfunction or creatinine clearance < 50 mL/min must not be treated with PEG-Intron -Rebetol
  • Pregnant women, women who plan to become pregnant, male subjects whose partner wants to become pregnant, and breastfeeding women.
Show all 32Show fewer
  • Suspected hypersensitivity to any interferon or ribavirin product.
  • Subject has used any investigational product within 30 days prior to enrollment
  • Subject is participating in any other clinical study
  • Any cause of liver disease other than chronic hepatitis C, including but not limited to:
  • Hemochromatosis
  • Alpha-1 antitrypsin deficiency
  • Wilson's disease
  • Autoimmune hepatitis
  • Alcoholic liver disease
  • Non-alcoholic steatohepatitis (NASH)
  • Drug-related liver disease
  • Active malignant disease or suspicion or history of malignant disease within five previous years (except for adequately treated basal cell carcinoma)
  • Known coagulation diseases such as hemophilia; hemoglobin diseases (e.g. thalassemia)
  • Known G6PD deficiency
  • Evidence of advanced liver disease such as history or presence of ascites, bleeding varices, or hepatic encephalopathy.
  • Subjects with organ transplants, except for corneal or hair transplant.
  • Any known preexisting medical condition that could interfere with the subject's participation in and completion of study, such as:
  • Preexisting psychiatric condition, especially moderate to severe depression, or a history of severe psychiatric disorder, such as psychosis, suicidal ideation, or suicide attempts. Severe depression includes the following: hospitalization for depression; electroconvulsive therapy for depression; or depression causing a prolonged absence from work or significantly altering daily functions. Subjects with mild depression may be considered for entry into the study provided that a pre-treatment assessment demonstrates that the subject's emotional status is clinically stable, in which case a management plan must be formulated for the subject; this management plan will become a part of the subject's medical record.
  • Craniocerebral trauma which is not a concussion or active seizure disorders requiring medication.
  • Clinically significant ECG abnormalities and/or cardiovascular dysfunction within 6 previous months (e.g., angina, congestive heart failure, recent myocardial infarction, or significant arrhythmia).
  • Chronic lung disease (e.g., chronic obstructive lung disease)
  • Poorly controlled diabetes mellitus
  • Immune-mediated disease (e.g., inflammatory bowel disease [Crohn's disease, ulcerative colitis], idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis)
  • Clinical gout
  • Subject is or was a substance abuser, such as alcohol (80 gm/day or more), methadone, IV, oral or inhaled drugs. To be considered for inclusion into the protocol, the subject must have abstained and agree to abstain from using any of the above for at least 6 months. Subjects treated with buprenorphine (Subutex) who have been stable for 6 months may be included
  • Any other condition that, in the investigator's opinion, could determine that subject's participation in the study is not indicated or could interfere with the subject's participation in and completion of study.

About this study

Official title: Comparison of Three Regimens of PEG-Intron and Ribavirin in the Treatment of Chronic Hepatitis C, Genotype 2 or 3, in Previously Untreated Patients

This is a randomized, open-label, multinational study designed to evaluate the "standard" regimen, PegIntron 1.5 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg daily [Arm PEG2b 1.5/R (24 weeks)], compared to a lower dose regimen, PegIntron 1.0 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg daily [Arm PEG2b 1.0/R (24 weeks)], using a 24 week treatment duration for both arms. Additionally, the study examined the efficacy of reduced treatment duration: PegIntron 1.5 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg for 16 weeks [Arm PEG2b 1.5/R (16 weeks)] .

Read the detailed description

This is a randomized, open-label, multinational study designed to evaluate the "standard" regimen, PegIntron 1.5 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg daily [Arm PEG2b 1.5/R (24 weeks)], compared to a lower dose regimen, PegIntron 1.0 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg daily [Arm PEG2b 1.0/R (24 weeks)], using a 24 week treatment duration for both arms. Additionally, the study examined the efficacy of reduced treatment duration: PegIntron 1.5 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg for 16 weeks [Arm PEG2b 1.5/R (16 weeks)].

Being tested
peginterferon alfa-2b (SCH 54031), ribavirin (SCH 18908)
Keywords
Hepatitis C, Chronic, Genotype 2 and Genotype 3
Medical subject headings
Hepatitis C, Chronic

What participants receive

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

  • peginterferon alfa-2b (SCH 54031)Biological

    Also called PegIntron (SCH 54031)

    1.5 mcg/kg QW SC for 24 weeks

  • peginterferon alfa-2b (SCH 54031)Biological

    Also called PegIntron (SCH 54031)

    1.0 mcg/kg QW SC for 24 weeks

  • peginterferon alfa-2b (SCH 54031)Biological

    Also called PegIntron (SCH 54031)

    1.5 mcg/kg QW SC for 16 weeks

  • ribavirin (SCH 18908)Drug

    Also called REBETOL (SCH 18908)

    800-1200 mg daily for 24 weeks

  • ribavirin (SCH 18908)Drug

    Also called REBETOL (SCH 18908)

    800-1200 mg daily for 16 weeks

Study groups in NCT00302081
Study groupRoleWhat they receive
PEG2b 1.5/R (24 weeks)Active comparatorPegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg daily for 24 weeks
Receives: Biological: peginterferon alfa-2b (SCH 54031); Drug: ribavirin (SCH 18908)
PEG 2b 1.0/R (24 weeks)ExperimentalPegIntron (peginterferon alfa-2b; SCH 54031) 1.0 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 24 weeks
Receives: Biological: peginterferon alfa-2b (SCH 54031); Drug: ribavirin (SCH 18908)
PEG2b 1.5/R (16 weeks)ExperimentalPegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 16 weeks
Receives: Biological: peginterferon alfa-2b (SCH 54031); Drug: ribavirin (SCH 18908)

What is being measured

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

  1. The Number of Participants Who Achieve a Sustained Virologic Response (SVR)

    A sustained virologic response is defined as undetectable hepatitis C virus ribonucleic acid [HCV-RNA] 24 weeks post-treatment. Serum HCV-RNA is measured by HCV-PCR in local laboratories. HCV-RNA below the limit of detection is considered undetectable.

    Measured: 24-week treatment duration for Arms [Peg2b 1.5/R(24 weeks)] and [PEG2b 1.0/R(24 weeks]); 16-week treatment duration for Arm [PEG2b 1.5/R(16 weeks]. Follow-up of 24 weeks for each arm.

Secondary outcomes (1)

  1. Virologic Response Rates at the End of Therapy. Biochemical Responses as Determined by ALT and AST Levels at the End of Treatment and at the End of Follow up.

    Virologic response is defined as undetectable hepatitis C virus ribonucleic acid (HCV-RNA) in the serum. A blood test is used to measure the level of ALT and AST. ALT response was defined as ALT<40 IU/L (international units per liter).

    This was not a prespecified key secondary outcome.

    Measured: End of treatment: 24 weeks for arms [PEG2b 1.5/R (24 weeks)] and [PEG2b 1.0/R (24 weeks)]; 16 weeks for arm [PEG2b 1.5/R (16 weeks)]. Follow-up of 24 weeks for each arm.

Timeline

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

  1. First posted13 Mar 2006 (estimated)
  2. Study startAug 2003
  3. Primary completionApr 2008
  4. Study completionApr 2008

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
696 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00302081
Sponsor's protocol ID
P03548
Status last verified
Mar 2017
First submitted
10 Mar 2006
Last updated
5 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

Publications

  • Manns M, Zeuzem S, Sood A, Lurie Y, Cornberg M, Klinker H, Buggisch P, Rossle M, Hinrichsen H, Merican I, Ilan Y, Mauss S, Abu-Mouch S, Horban A, Muller TH, Welsch C, Chen R, Faruqi R, Pedicone LD, Wedemeyer H. Reduced dose and duration of peginterferon alfa-2b and weight-based ribavirin in patients with genotype 2 and 3 chronic hepatitis C. J Hepatol. 2011 Sep;55(3):554-563. doi: 10.1016/j.jhep.2010.12.024. Epub 2011 Jan 13.

    PubMed 21237227

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing peginterferon alfa-2b (SCH 54031) and ribavirin (SCH 18908) in people with Hepatitis C, Chronic, 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 18 inclusion and 32 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 5 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 11 Aug 2009). 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?

The Number of Participants Who Achieve a Sustained Virologic Response (SVR) (time frame: 24-week treatment duration for Arms [Peg2b 1.5/R(24 weeks)] and [PEG2b 1.0/R(24 weeks]); 16-week treatment duration for Arm [PEG2b 1.5/R(16 weeks]. Follow-up of 24 weeks for each arm.). 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 NCT00302081, which also lists 1 linked publication.

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 5 Apr 2017.

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