Hepatitis C, ChronicPhase 3NCT00686881

Efficacy of Peginterferon Alfa-2b (SCH 054031) vs Glycyrrhizin in Interferon (IFN)-Treated Patients With Chronic Hepatitis C and F2/F3 Liver Fibrosis (P04773)

A Phase 3 study testing Peginterferon alfa-2b (PegIFN-2b) and Comparator: Stronger neo minophagen C (SNMC) in people with Hepatitis C, Chronic, run by Merck Sharp & Dohme LLC.

Terminated

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

Official record

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Trial summary

Who is it for?: Ages 20 years and older
Conditions the study is for: Hepatitis C, Chronic
What is being tested?: Peginterferon alfa-2b (PegIFN-2b) and Comparator: Stronger neo minophagen C (SNMC)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 261 participants
Where: No sites listed yet
Study dates: Dec 2006to Feb 2011
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 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with chronic hepatitis C previously treated with interferon
At least 20 years of age
Liver fibrosis score rated as F2 or F3 based on the result of liver biopsy at screening
Female patients willing to use contraception
Body weight from 35.0 kg to 110.0 kg (inclusive)
Positive for hepatitis C virus ribonucleic acid (HCV-RNA) by qualitative assay

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Patients who meet the following laboratory criteria:
Serum alanine aminotransferase (ALT) level: >60 IU/L
Neutrophil count: >=1,200/mm^3
Platelet count: >=100,000/mm^3
Serum potassium level: >=3.5 mEq/L

Who cannot join

Patients who received interferon therapy within 90 days of Screening
Patients who have received antiviral agents or antitumor agents, or immunomodulator therapy (including chronic glucocorticoids and radiotherapy) within 90 days of Screening (excluding local administration and topical use)
Patients who have received other investigational drugs within 90 days of Screening
Hepatitis B surface antigen (HBs)positive
Antinuclear antibody titer of 1:320 or higher
Creatinine level exceeding the upper limit of the reference range measured at screening test 2;

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Fasting blood glucose level of >=126 mg/dL
Patients on insulin therapy regardless of the fasting blood glucose level
Patients who have a concurrent or past history of any of the following conditions: liver cirrhosis, liver failure, or liver carcinoma; hepatic encephalopathy, esophageal varices requiring treatment, or ascites; suicidal attempt or ideation; epileptic seizures requiring drug therapy; angina pectoris, heart failure, myocardial infarction or fatal arrhythmia; autoimmune disease (Hashimoto's disease [chronic thyroiditis], Crohn's disease, ulcerative colitis, rheumatoid arthritis, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, etc.); malignant tumors (it is permitted to register patients with at least 5 years after cure).
Patients who concurrently have any of the following conditions: liver disease such as autoimmune hepatitis, alcoholic liver injury, and drug-induced hepatitis; hemophilia; depression or schizophrenia which requires treatment; hypertension which cannot be controlled by drug therapy or arrhythmia which requires treatment, chronic pulmonary disease; abnormal thyroid function that cannot be controlled by drug therapy; organ transplants (other than corneal, hair transplant, etc.); aldosteronism, myopathy, or hypokalemia.
Patients with a history of hypersensitivity to interferon preparations or biological products such as vaccines
Patients with a history of hypersensitivity to monoammonium glycyrrhizinate, glycine, or L-cysteine monohydrochloride;
Women who are pregnant or lactating, and women in whom pregnancy cannot be ruled out based on the result of serum human chorionic gonadotropin (HCG) measurement at Screening

About this study

Official title: A Clinical Study of SCH 54031 as Monotherapy in IFN-treated Patients With Chronic Hepatitis C

The objective of this study is to compare the efficacy of peginterferon alfa-2b (PegIFN-2b) monotherapy administered at a dose of 0.5 ug/kg vs stronger neo minophagen C (SNMC) in participants with chronic hepatitis C (CHC) and liver fibrosis (Metavir fibrosis score of F2 and F3) who were previously treated with interferon. The trial will evaluate the effect of treatment on the progression of liver fibrosis, liver inflammation, and liver function. Treatment will be administered for up to 156 weeks with a 4-week follow-up.

Conditions: Hepatitis C, Chronic
Being tested: Peginterferon alfa-2b (PegIFN-2b), Comparator: Stronger neo minophagen C (SNMC)
Keywords: hepatitis C
Medical subject headings: Hepatitis C, Chronic, Hepatitis C

What participants receive

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

Peginterferon alfa-2b (PegIFN-2b)Biological
Also called SCH 054031, Pegylated interferon alfa-2b
PegIFN-2b administered at a dose of 0.5 ug/kg SC once a week for 156 weeks
Comparator: Stronger neo minophagen C (SNMC)Drug
SNMC (as glycyrrhizin-containing compound) administered at 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for 156 weeks .

Study groups in NCT00686881
Study group	Role	What they receive
PegIFN-2b	Experimental	Participants receiving PegIFN-2b at 0.5 ug/kg subcutaneously (SC) once a week for up to 156 weeks. Receives: Biological: Peginterferon alfa-2b (PegIFN-2b)
SNMC	Active comparator	Participants receiving SNMC 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for up to 156 weeks. Receives: Drug: Comparator: Stronger neo minophagen C (SNMC)

What is being measured

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

Number of Participants With Change in Metavir Fibrosis Score
Metavir fibrosis score is a 5-point scale based on the amount of fibrosis in the liver, ranging from F0 (best, no fibrosis) to F4 (worst, cirrhosis).
Measured: Baseline and discontinuation of treatment (up to 156 weeks)

Secondary outcomes (2)

Number of Participants With Alanine Aminotransferase (ALT) Normalization of >16 Weeks Duration
The ALT was judged to have been normalized when the ALT level was 35 IU/L or below.
Measured: Week 24
Number of Participants With Change in Metavir Inflammation Score
Metavir inflammation score is a 4-point scale based on the severity of inflammation in the liver, ranging from A0 (best, no activity) to A3 (worst, severe activity).
Measured: Baseline and Week 48

Timeline

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

Dec 2006Feb 2011

First posted30 May 2008 (estimated)
Study startDec 2006
Primary completionFeb 2011
Study completionFeb 2011

Why it stopped: This study was terminated due to low enrollment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 261 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00686881
Sponsor's protocol ID: P04773
Other IDs: JPC-05-356-30
Status last verified: Mar 2017
First submitted: 27 May 2008
Last updated: 6 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
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All Hepatitis C, Chronic trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinical Study of SCH 54031 as Monotherapy in IFN-treated Patients With Chronic Hepatitis C
ClinicalTrials.gov ID: NCT00686881
Acronym / sponsor ID: P04773
Conditions: Hepatitis C, Chronic
Keywords: hepatitis C
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: This study was terminated due to low enrollment
Enrolment: 261 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Dec 2006
Primary completion: Feb 2011 (actual)
Study completion: Feb 2011 (actual)
First posted: 30 May 2008 (estimated)
Results: Posted 6 Mar 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
PegIFN-2b	Experimental	Biological: Peginterferon alfa-2b (PegIFN-2b)Participants receiving PegIFN-2b at 0.5 ug/kg subcutaneously (SC) once a week for up to 156 weeks.
SNMC	Active comparator	Drug: Comparator: Stronger neo minophagen C (SNMC)Participants receiving SNMC 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for up to 156 weeks.

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Patients with chronic hepatitis C previously treated with interferon
At least 20 years of age
Liver fibrosis score rated as F2 or F3 based on the result of liver biopsy at screening
Female patients willing to use contraception
Body weight from 35.0 kg to 110.0 kg (inclusive)

Key exclusion criteria (13 listed)

Patients who received interferon therapy within 90 days of Screening
Patients who have received antiviral agents or antitumor agents, or immunomodulator therapy (including chronic glucocorticoids and radiotherapy) within 90 days of Screening (excluding local administration and topical use)
Patients who have received other investigational drugs within 90 days of Screening
Hepatitis B surface antigen (HBs)positive
Antinuclear antibody titer of 1:320 or higher

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Peginterferon alfa-2b (PegIFN-2b)Also: SCH 054031, Pegylated interferon alfa-2bPegIFN-2b administered at a dose of 0.5 ug/kg SC once a week for 156 weeks	Biological	PegIFN-2b
Comparator: Stronger neo minophagen C (SNMC)SNMC (as glycyrrhizin-containing compound) administered at 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for 156 weeks .	Drug	SNMC

Primary outcome

Number of Participants With Change in Metavir Fibrosis Score
Time frame: Baseline and discontinuation of treatment (up to 156 weeks)
Metavir fibrosis score is a 5-point scale based on the amount of fibrosis in the liver, ranging from F0 (best, no fibrosis) to F4 (worst, cirrhosis).

2 secondary outcomes

Number of Participants With Alanine Aminotransferase (ALT) Normalization of >16 Weeks Duration
Time frame: Week 24
Number of Participants With Change in Metavir Inflammation Score
Time frame: Baseline and Week 48

Results and safety

Results posted to the registry on 6 Mar 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PegIFN-2b	127	45
SNMC	134	53

Primary outcome: Number of Participants With Change in Metavir Fibrosis Score

Time frame: Baseline and discontinuation of treatment (up to 156 weeks). Number. Unit: Participants

Measure	PegIFN-2b n = 123	SNMC n = 126
Participants with ≥1grade lower score (improved)	13	11
Participants with no change in score	79	79
Participants with ≥1 grade higher score (worsened)	31	36

Population analysed: All treated participants excluding 2 participants on the PegIFN-2B arm and 1 participant on the SNMC arm for whom baseline data were non-evaluable or for whom no post-baseline data were available.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PegIFN-2b	32 of 125 (25.6%)	125 of 125 (100%)	Not reported
SNMC	23 of 127 (18.1%)	123 of 127 (96.9%)	Not reported

Limitations and caveats (from the sponsor): This study was prematurely discontinued because of low enrollment.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: 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

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Peginterferon alfa-2b (PegIFN-2b) and Comparator: Stronger neo minophagen C (SNMC) 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 11 inclusion and 13 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 6 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 6 Mar 2012). 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 Change in Metavir Fibrosis Score (time frame: Baseline and discontinuation of treatment (up to 156 weeks)). 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 NCT00686881.

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 6 Apr 2017.