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Hepatitis C, ChronicPhase 3NCT00081770

Peginterferon Dose Evaluations for Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1 (Study P03471)

A Phase 3 study testing PegIntron (peginterferon alfa-2b; SCH 54031), REBETOL (ribavirin; SCH 18908) and PEGASYS (peginterferon alfa-2a) 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

The objective is to compare the safety and efficacy of the following three treatment regimens in previously untreated adult subjects with chronic hepatitis C infected with Genotype 1: (1) PegIntron 1.5 µg/kg/wk in combination with weight based REBETOL (800-1400 mg/day); (2) PegIntron 1µg/kg/wk in combination with… 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?
PegIntron (peginterferon alfa-2b; SCH 54031), REBETOL (ribavirin; SCH 18908) and PEGASYS (peginterferon alfa-2a)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,469 participants
Where
No sites listed yet
Study dates
Mar 2004to Nov 2007
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

  • Previously untreated adults with chronic hepatitis C (hepatitis C virus ribonucleic acid [HCV RNA] quantitative polymerase chain reaction [qPCR] plasma positive)
  • Individuals with HCV genotype 1 (mixed 1a/1b is acceptable)
  • Compensated liver disease
  • Pretreatment liver biopsy slides available
  • Adults aged 18-70
  • Individuals weighing 88-275 pounds (40-125 kg)
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  • Free from substance abuse for past 2 years
  • Those suffering from diabetes and/or hypertension must have normal eye exams and retinal photographs (these will be done as part of the study before hepatitis C treatment is given)
  • Patients and partners of patients willing to use adequate contraception during the course of the study
  • Hematology laboratory results of:
  • Hemoglobin (HGB) ≥ 12 g/dL for females or ≥ 13g/dL for males
  • White Blood Cell Count (WBC) ≥ 3,000/mm^3
  • Neutrophils ≥ 1,500/mm^3
  • Platelets ≥ 80,000/mm^3
  • Chemistry laboratory results of:
  • Normal Thyroid Stimulating Hormone (TSH), albumin, creatinine, and direct bilirubin
  • Antinuclear antibody (ANA) ≤ 1:320
  • Fasting Glucose 70-140 mg/dL Note: If glucose levels are between 116-140 mg/dL or an individual has diabetes, glycosylated hemoglobin [HbA1C] must be ≤ 8.5%

Who cannot join

  • Previous hepatitis C treatment
  • Pregnant women or partners of pregnant women
  • Patients or partners of patients who intend to become pregnant any time during the 48 weeks
  • Women who are breastfeeding
  • Individuals with liver disease not caused by hepatitis C
  • Individuals infected with the hepatitis B virus and/or human immunodeficiency virus (HIV)
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  • Patients with a history of liver cancer (hepatocellular carcinoma)
  • Known blood disorders such as hemoglobinopathy, coagulopathy, or glucose-6-phosphate dehydrogenase [G6PD] deficiency
  • Body organ transplant
  • Any known or suspected cancer within the past 5 years
  • Individuals who currently use epoetin [EPO], granulocyte colony stimulating factor [G-CSF] and/or granulocyte monocyte colony stimulating factor [GM-CSF]
  • Those having a history of or active clinical gout
  • Individuals who have chronic pulmonary disease
  • Individuals who have a medical condition that would likely require systemic steroids
  • Those with a history of central nervous system (CNS trauma) or seizure disorders
  • Current or previous use of lithium or antipsychotic drugs
  • Individuals who currently have or show signs of moderate to severe depression or history of significant psychiatric disorders
  • Patients with clinically significant electrocardiogram (ECG) abnormalities
  • Individuals with serious heart problems such as those who have had a heart attack, uncontrolled high blood pressure, or other heart problems
  • Patients that weigh > 231-275 pounds (105-125 kg) AND have a body mass index (BMI) > 30 AND have 3 or more of the risk factors below: (a) Strong family history of coronary heart disease (CHD) which includes 2 or more first-degree relatives with CHD or family history of early CHD at age < 55 for male relatives or < 65 for female relatives (b) Individuals with abnormal total cholesterol and/or sub fractions (uncontrolled hypercholesterolemia) (c) Diabetes (d) Hypertension (e) Smoking

About this study

Official title: Comparison of PEG-Intron 1.5µg/kg/wk Plus REBETOL vs PEG-Intron 1µg/kg/wk Plus REBETOL vs PEGASYS 180µg/wk Plus COPEGUS in Previously Untreated Adult Subjects With Chronic Hepatitis C Infected With Genotype 1

The objective is to compare the safety and efficacy of the following three treatment regimens in previously untreated adult subjects with chronic hepatitis C infected with Genotype 1: (1) PegIntron 1.5 µg/kg/wk in combination with weight based REBETOL (800-1400 mg/day); (2) PegIntron 1µg/kg/wk in combination with weight based REBETOL (800-1400 mg/day); and (3) PEGASYS 180 µg/wk plus COPEGUS 1000-1200 mg/day.

Read the detailed description

PegIntron Dose will be administered once weekly subcutaneously on the same day of the week:

Screening 2 Weight 40-50 kg Volume to Inject (mL) 0.22; Screening 2 Weight 51-60 kg Volume to Inject (mL) 0.28; Screening 2 Weight 61-75 kg Volume to Inject (mL) 0.33; Screening 2 Weight 76-85 kg Volume to Inject (mL) 0.41; Screening 2 Weight 86-104 kg Volume to Inject (mL) 0.48; Screening 2 Weight 105-125 kg Volume to Inject (mL) 0.58 from two vials

REBETOL Dosage (for Use With PegIntron):

Screening 2 Weight 40-65 kg Daily Dose 800 mg; Screening 2 Weight >65-85 kg Daily Dose 1000 mg; Screening 2 Weight >85-105 kg Daily Dose 1200 mg; Screening 2 Weight >105-125 kg Daily Dose 1400 mg

The PEGASYS dose of 1 mL (180 µg) will be administered once weekly subcutaneously on the same day of the week

COPEGUS Dosage (for Use With PEGASYS):

Screening 2 Weight <75 kg Daily Dose 1000 mg; Screening 2 Weight > or = 75 kg Daily Dose 1200mg

NOTE: Double Blind for PegIntron; Open Label for REBETOL, PEGASYS and COPEGUS

NOTE: REBETOL is the Schering-Plough brand name for ribavirin. COPEGUS is the Hoffman-La Roche brand name for ribavirin.

Being tested
PegIntron (peginterferon alfa-2b; SCH 54031), REBETOL (ribavirin; SCH 18908), PEGASYS (peginterferon alfa-2a), COPEGUS (ribavirin)
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.

  • PegIntron (peginterferon alfa-2b; SCH 54031)Biological

    Also called PegIntron

    1.5 ug/kg/week subcutaneously (SC) for 48 weeks

  • PegIntron (peginterferon alfa-2b; SCH 54031)Biological

    Also called PegIntron

    1.0 ug/kg/week SC for 48 weeks

  • REBETOL (ribavirin; SCH 18908)Drug

    Also called REBETOL [the Schering-Plough brand name for ribavirin]

    weight based dose 800-1400 mg/day orally (PO) for 48 weeks

  • PEGASYS (peginterferon alfa-2a)Biological

    Also called PEGASYS

    180 ug/week SC administered for 48 weeks

  • COPEGUS (ribavirin)Drug

    Also called COPEGUS [the Hoffman-La Roche brand name for ribavirin]

    1000-1200 mg/day PO for 48 weeks

Study groups in NCT00081770
Study groupRoleWhat they receive
PegIntron 1.5 ug/kg/wk plus REBETOLExperimentalPegIntron (peginterferon alfa-2b; SCH 54031) 1.5 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
Receives: Biological: PegIntron (peginterferon alfa-2b; SCH 54031); Drug: REBETOL (ribavirin; SCH 18908)
PegIntron 1.0 ug/kg/wk plus REBETOLExperimentalPegIntron (peginterferon alfa-2b; SCH 54031) 1.0 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
Receives: Biological: PegIntron (peginterferon alfa-2b; SCH 54031); Drug: REBETOL (ribavirin; SCH 18908)
PEGASYS 180 ug/wk Plus COPEGUSActive comparatorPEGASYS (peginterferon alfa-2a) 180 ug/week plus COPEGUS (ribavirin) 1000-1200 mg/day administered for 48 weeks with 24-week post-treatment follow-up
Receives: Biological: PEGASYS (peginterferon alfa-2a); Drug: COPEGUS (ribavirin)

What is being measured

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

  1. Sustained Virologic Response (SVR) Rate

    SVR rate is the percentage of participants with undetectable hepatitis C virus ribonucleic acid (HCV-RNA) at the end of the 24-week post-treatment follow-up.

    Measured: Assessed at the end of a 24-week post-treatment follow-up

Secondary outcomes (3)

  1. Mean Change From Baseline in the Log Viral Load at Treatment Week 4

    The difference between viral load levels in the blood at the start of the study and Treatment Week 4, expressed in terms of a logarithmic scale with base 10, and averaged for all the participants in each treatment group.

    Measured: Assessed at Baseline and Treatment Week 4

  2. Virologic Response Rate at Treatment Week 12

    Percentage of participants with undetectable hepatitis C RNA (HCV-RNA) at Treatment Week 12

    Measured: Assessed at Treatment Week 12

  3. Mean Change From Baseline in the Log Viral Load at Treatment Week 2

    The difference between viral load levels in the blood at the start of the study and Treatment Week 2, expressed in terms of a logarithmic scale with base 10, and averaged for all the participants in each treatment group.

    Measured: Assessed at Baseline and Treatment Week 2

Timeline

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

  1. First posted22 Apr 2004 (estimated)
  2. Study startMar 2004
  3. Primary completionNov 2007
  4. Study completionNov 2007

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
4,469 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00081770
Sponsor's protocol ID
P03471
Other IDs
2552898
Status last verified
Mar 2017
First submitted
20 Apr 2004
Last updated
4 Apr 2017
Data monitoring committee
Yes
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

  • McHutchison JG, Lawitz EJ, Shiffman ML, Muir AJ, Galler GW, McCone J, Nyberg LM, Lee WM, Ghalib RH, Schiff ER, Galati JS, Bacon BR, Davis MN, Mukhopadhyay P, Koury K, Noviello S, Pedicone LD, Brass CA, Albrecht JK, Sulkowski MS; IDEAL Study Team. Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection. N Engl J Med. 2009 Aug 6;361(6):580-93. doi: 10.1056/NEJMoa0808010. Epub 2009 Jul 22.

    PubMed 19625712

  • Melia MT, Muir AJ, McCone J, Shiffman ML, King JW, Herrine SK, Galler GW, Bloomer JR, Nunes FA, Brown KA, Mullen KD, Ravendhran N, Ghalib RH, Boparai N, Jiang R, Noviello S, Brass CA, Albrecht JK, McHutchison JG, Sulkowski MS; IDEAL Study Team. Racial differences in hepatitis C treatment eligibility. Hepatology. 2011 Jul;54(1):70-8. doi: 10.1002/hep.24358.

    PubMed 21488082

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PegIntron (peginterferon alfa-2b; SCH 54031), REBETOL (ribavirin; SCH 18908) and PEGASYS (peginterferon alfa-2a) 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 20 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 4 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 30 Oct 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?

Sustained Virologic Response (SVR) Rate (time frame: Assessed at the end of a 24-week post-treatment follow-up). 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 NCT00081770, which also lists 2 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 4 Apr 2017.

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