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Hepatitis C, ChronicPhase 2NEXT-1NCT00797745

A Pharmacokinetics/Pharmacodynamics Study of SCH 900518 in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C (Protocol No. P05104AM2)(COMPLETED)

A Phase 2 study testing peginterferon alfa 2b, ribavirin and SCH 900518 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

SCH 900518 is a potent oral inhibitor of HCV NS3 protease which disrupts hepatitis C virus (HCV) polyprotein processing. SCH 900518, when added to the current standard of care (SOC), peginterferon-alfa plus ribavirin, would likely increase the proportion of patients achieving undetectable HCV-RNA levels and sustained… Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Hepatitis C, Chronic
What is being tested?
peginterferon alfa 2b, ribavirin and SCH 900518
Could I receive a placebo?
No, everyone receives an active treatment
How many people
111 participants
Where
No sites listed yet
Study dates
Nov 2008to Sep 2010
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Adult subjects with CHC HCV genotype 1 with no previous treatment for CHC
  • 18 to 55 years of age
  • Weight between 40 and 125 kg
  • Previously documented CHC genotype 1 infection
  • Liver biopsy within 2 years of Screening with histology consistent with chronic hepatitis C and no evidence of bridging fibrosis or cirrhosis
  • Subject and subject's partner(s) must each agree to use acceptable methods of contraception for at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study drug
  • Subjects must be willing to give written informed consent

Who cannot join

  • Prior treatment for hepatitis C other than herbal remedies
  • HIV positive or known to be co-infected with hepatitis B
  • Medically significant gallbladder or hepatobiliary findings on Screening ultrasound
  • Use of any known significant inducers or substrates of CYP3A4 two weeks prior to start of study medications
  • Use of herbal supplements (Milk Thistle permitted)
  • Diabetic and hypertensive subjects with clinically significant ocular examination findings
Show all 27Show fewer
  • Current moderate or severe depression
  • History of depression associated with any of the following:
  • Hospitalization for depression
  • Electroconvulsive therapy for depression.
  • Depression that resulted in a prolonged absence from work and/or significant disruption of daily functions
  • Suicidal or homicidal ideation and/or attempt
  • History of severe psychiatric disorders
  • Past history or current use of lithium
  • Clinical diagnosis of substance abuse of alcohol, intravenous drugs, inhalational (not including marijuana), psychotropics, narcotics, cocaine use, prescription or over-the-counter drugs within 5 years of Day 1
  • Past or current use of opiate agonist substitution therapy
  • Any known pre-existing medical condition (CNS, cardiac, pulmonary, immune mediated) that could interfere with the subject's participation in and completion of the study
  • Active clinical gout within the last year
  • Hemoglobinopathy or coagulopathy
  • Myelodysplastic syndromes
  • Organ transplants other than cornea and hair
  • Poor venous access that precludes routine peripheral blood sampling or an indwelling venous catheter
  • Subjects with a history of gastric surgery (eg, stapling, banding, bypass) or subjects with a history of malabsorption disorders (eg, celiac sprue disease)
  • Evidence of active or suspected malignancy, or a history of malignancy, within the last 5 years (except adequately treated basal cell carcinoma of the skin). Subjects under evaluation for malignancy are not eligible.
  • Subjects who are pregnant or nursing
  • Subjects who intend to become pregnant during the study period
  • Male subjects with partners who are, or intend to become, pregnant during the study period

About this study

Official title: A Study of SCH 900518 in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C (Protocol No. P05104)

SCH 900518 is a potent oral inhibitor of HCV NS3 protease which disrupts hepatitis C virus (HCV) polyprotein processing. SCH 900518, when added to the current standard of care (SOC), peginterferon-alfa plus ribavirin, would likely increase the proportion of patients achieving undetectable HCV-RNA levels and sustained virologic response (SVR). In this study, SCH 900518 would be used in combination with low doses of ritonavir to enhance the levels of SCH 900518 within the body and reduce the number of daily SCH 900518 tablets required. The purpose of this study is to identify the optimal dose and schedule (once or twice a day) of SCH 900518 plus ritonavir in previously untreated patients with genotype 1 chronic hepatitis C when given in combination with SOC. The study compares SOC to 6 experimental arms. In the experimental arms, SOC plus SCH 900518 doses of 200, 400 and 600 mg once daily or 100 mg twice daily with ritonavir 100 mg once or twice daily will be explored. The benefits of a 4 week lead-in with PegIntron and ribavirin prior to the addition of SCH 900518 will also be explored.

Being tested
peginterferon alfa 2b, ribavirin, SCH 900518, ritonavir
Keywords
genotype 1 infection
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 2bBiological

    Also called PegIntron

    1.5 mcg/kg subcutaneously weekly for up to 24 or 48 weeks

  • ribavirinDrug

    Also called REBETOL

    ribavirin 600 to 1400 mg daily (weight-based dosing) by mouth twice daily for up to 24 or 48 weeks

  • SCH 900518Drug

    SCH 900518 100 mg tablets taken as 200 mg PO QD, 100 mg PO BID, 400 mg PO QD, or 600 mg PO QD for 12 weeks.

  • ritonavirDrug

    Also called Norvir

    Ritonavir 100 mg capsules taken as 100 mg PO QD or 100 mg PO BID for 12 weeks.

Study groups in NCT00797745
Study groupRoleWhat they receive
Standard of CareActive comparatorPegIntron 1.5 mcg/kg SC weekly plus ribavirin 600 to 1400 mg daily (weight-based) by mouth twice daily for 48 weeks. * Subjects with >= 1 log decrease from baseline in HCV-RNA levels after 12 weeks, but still above the lower limit of quantitation, have the option of crossing over to PegIntron, ribavirin plus SCH 900518 400 mg and ritonavir 100 mg daily for 12 weeks. This is followed by standard of care, PegIntron and ribavirin, for a total treatment duration of up to 48 weeks.
Receives: Biological: peginterferon alfa 2b; Drug: ribavirin; Drug: SCH 900518; Drug: ritonavir
2ExperimentalPegIntron 1.5 mcg/kg SC weekly plus ribavirin 600 to 1400 mg daily (weight-based) by mouth twice daily plus SCH 900518 200 mg daily plus ritonavir 100 mg daily for 12 weeks. Depending on HCV-RNA levels after 4 weeks of SCH 900518, patients will receive an additional 12 or 36 weeks of PegIntron/ribavirin. Total treatment duration will be 24 or 48 weeks.
Receives: Biological: peginterferon alfa 2b; Drug: ribavirin; Drug: SCH 900518; Drug: ritonavir
3ExperimentalPegIntron 1.5 mcg/kg SC weekly plus ribavirin 600 to 1400 mg daily (weight-based) by mouth twice daily plus SCH 900518 400 mg daily plus ritonavir 100 mg daily for 12 weeks. Depending on HCV-RNA levels after 4 weeks of SCH 900518, patients will receive an additional 12 or 36 weeks of PegIntron/ribavirin. Total treatment duration will be 24 or 48 weeks.
Receives: Biological: peginterferon alfa 2b; Drug: ribavirin; Drug: SCH 900518; Drug: ritonavir
4Experimental4 week lead-in with PegIntron 1.5 mcg/kg SC weekly plus ribavirin 600 to 1400 mg daily (weight-based) by mouth twice daily followed by PegIntron plus ribavirin plus SCH 900518 200 mg daily plus ritonavir 100 mg daily for 12 weeks. Depending on HCV-RNA levels after 4 weeks of SCH 900518, patients will receive an additional 8 or 32 weeks of PegIntron/ribavirin. Total treatment duration will be 24 or 48 weeks.
Receives: Biological: peginterferon alfa 2b; Drug: ribavirin; Drug: SCH 900518; Drug: ritonavir
5Experimental4 week lead-in with PegIntron 1.5 mcg/kg SC weekly plus ribavirin 600 to 1400 mg daily (weight-based) by mouth twice daily followed by PegIntron plus ribavirin plus SCH 900518 400 mg daily plus ritonavir 100 mg daily for 12 weeks. Depending on HCV-RNA levels after 4 weeks of SCH 900518, patients will receive an additional 8 or 32 weeks of PegIntron/ribavirin. Total treatment duration will be 24 or 48 weeks.
Receives: Biological: peginterferon alfa 2b; Drug: ribavirin; Drug: SCH 900518; Drug: ritonavir
6ExperimentalPegIntron 1.5 mcg/kg SC weekly plus ribavirin 600 to 1400 mg daily (weight-based) by mouth twice daily plus SCH 900518 100 mg twice daily plus ritonavir 100 mg twice daily for 12 weeks. Depending on HCV-RNA levels after 4 weeks of SCH 900518, patients will receive an additional 12 or 36 weeks of PegIntron/ribavirin. Total treatment duration will be 24 or 48 weeks.
Receives: Biological: peginterferon alfa 2b; Drug: ribavirin; Drug: SCH 900518; Drug: ritonavir
7Experimental4 week lead-in with PegIntron 1.5 mcg/kg SC weekly plus ribavirin 600 to 1400 mg daily (weight-based) by mouth twice daily followed by PegIntron plus ribavirin plus SCH 900518 600 mg daily plus ritonavir 100 mg daily for 12 weeks. Depending on HCV-RNA levels after 4 weeks of SCH 900518, patients will receive an additional 8 or 32 weeks of PegIntron/ribavirin. Total treatment duration will be 24 or 48 weeks.
Receives: Biological: peginterferon alfa 2b; Drug: ribavirin; Drug: SCH 900518; Drug: ritonavir

What is being measured

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

  1. The primary efficacy endpoint is the proportion of subjects with undetectable HCV-RNA after 4 weeks of treatment with SCH 900518.

    Measured: After 4 weeks of treatment with SCH 900518

Secondary outcomes (3)

  1. Rate of viral decline during the first 4 weeks of dosing with SCH 900518

    Measured: After 4 and 12 weeks of treatment with SCH 900518, at EOT and FW 24

  2. Proportion of subjects with undetectable HCV-RNA at both 4 and 12 weeks of dosing with SCH 900518

    Measured: After 4 and 12 weeks of treatment with SCH 900518, at EOT and FW 24

  3. Proportion of subjects with undetectable HCV-RNA at end of treatment (EOT) and follow-up week 24 (FW24)

    Measured: After 4 and 12 weeks of treatment with SCH 900518, at EOT and FW 24

Timeline

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

  1. First posted25 Nov 2008 (estimated)
  2. Study startNov 2008
  3. Primary completionJul 2009
  4. Study completionSep 2010

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
111 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00797745
Sponsor's protocol ID
P05104
Acronym
NEXT-1
Status last verified
Jan 2015
First submitted
24 Nov 2008
Last updated
22 Jan 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing peginterferon alfa 2b, ribavirin and SCH 900518 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 7 inclusion and 27 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 22 Jan 2015. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 primary efficacy endpoint is the proportion of subjects with undetectable HCV-RNA after 4 weeks of treatment with SCH 900518. (time frame: After 4 weeks of treatment with SCH 900518). 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 NCT00797745.

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 22 Jan 2015.

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