Hepatitis C, ChronicPhase 4START 4NCT01606800

Efficacy and Safety of Short Course Therapy With Peginterferon Alpha-2b (PEG-IFN Alfa-2b) and Ribavirin (RBV) for Chronic Hepatitis C (Genotype 4) Participants Achieving a Rapid Virological Response at Week 4 of Treatment (MK-8908B-059)

A Phase 4 study testing PEG-IFN alfa-2b and ribavirin 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

The purpose of this study is to assess the efficacy of a short course of therapy (24 weeks) versus standard 48 week treatment in previously untreated adult participants with chronic hepatitis C (CHC) genotype 4 infection who achieve rapid virologic response (RVR), defined as HCV ribonucleic acid (RNA) negativity after… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hepatitis C, Chronic
What is being tested?: PEG-IFN alfa-2b and ribavirin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 45 participants
Where: No sites listed yet
Study dates: 1 Jan 2013to 26 Jan 2015
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participant is ≥40 kg and ≤120 kg weight
Participant and participant'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 medication, or longer if dictated by local regulations.
Previously documented CHC genotype 4 infection
Liver biopsy or fibrotest and fibroscan with histology consistent with CHC and no other etiology and with hepatic fibrosis scores (F0, F1, F2, F3).

Who cannot join

Co-infected with the human immunodeficiency virus (HIV) or hepatitis B virus
Treatment for hepatitis C with any investigational medication
Treatment with any investigational drug within 30 days of the screening visit
Evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy
Autoimmune hepatitis or a history of autoimmune disease
Hepatic fibrosis score F4

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Severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous six months
Autoimmune hepatitis or a history of autoimmune disease
Thyroid disease uncontrolled with conventional treatment
Epilepsy and/or compromised central nervous system (CNS) function

About this study

Official title: Randomized Open Label Study to Assess the Efficacy and Safety of Short Course Therapy (24 Weeks) With Peginterferon Alpha-2b and Ribavirin for Chronic Hepatitis C (Genotype 4) Patients Who Achieve a Rapid Virological Response (HCV -RNA Undetectable at Week 4 of Treatment)

Read the detailed description

Participants who achieved RVR after 4 weeks of PEG-INF alfa-2b plus RBV treatment were randomized to receive either 20 or 44 weeks of continued therapy, for a total of 24 or 48 weeks total of PEG-INF plus RBV therapy.

Conditions: Hepatitis C, Chronic
Being tested: PEG-IFN alfa-2b, 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.

PEG-IFN alfa-2bDrug
Pegylated interferon alfa-2b administered subcutaneously 1.5 mcg/kg/week
ribavirinDrug
Ribavirin 200 mg capsules administered orally daily based on weight

Study groups in NCT01606800
Study group	Role	What they receive
44 Weeks of PEG-IFN alfa-2b + RBV	Experimental	Participants achieving RVR at 4 weeks of treatment will receive 44 additional weeks of Peg-IFN Alfa-2b + RBV. Receives: Drug: PEG-IFN alfa-2b; Drug: ribavirin
20 Weeks of PEG-IFN alfa-2b + RBV	Experimental	Participants achieving RVR at 4 weeks of treatment will receive 20 additional weeks of Peg-IFN Alfa-2b + RBV. Receives: Drug: PEG-IFN alfa-2b; Drug: ribavirin

What is being measured

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

Number of Participants Achieving Sustained Virologic Response (SVR)
SVR was defined as undetectable HCV RNA levels 24 weeks after the completion of therapy.
Measured: At 24 weeks after the completion of therapy (up to 72 weeks)

Timeline

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

1 Jan 201326 Jan 2015

First posted28 May 2012 (estimated)
Study start1 Jan 2013
Primary completion26 Jan 2015
Study completion26 Jan 2015

Why it stopped: The trial was terminated due to change in new standard of therapy during the study period.

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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01606800
Sponsor's protocol ID: 8908B-059
Other IDs: MK-8908B-059
Acronym: START 4
Status last verified: Sep 2018
First submitted: 24 May 2012
Last updated: 25 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

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
Autoimmune Diseases, Lupus Erythematosus, Systemic

All Hepatitis C, Chronic trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Open Label Study to Assess the Efficacy and Safety of Short Course Therapy (24 Weeks) With Peginterferon Alpha-2b and Ribavirin for Chronic Hepatitis C (Genotype 4) Patients Who Achieve a Rapid Virological Response (HCV -RNA Undetectable at Week 4 of Treatment)
ClinicalTrials.gov ID: NCT01606800
Acronym / sponsor ID: START 4 / 8908B-059
Conditions: Hepatitis C, Chronic
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: The trial was terminated due to change in new standard of therapy during the study period.
Enrolment: 45 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 1 Jan 2013 (actual)
Primary completion: 26 Jan 2015 (actual)
Study completion: 26 Jan 2015 (actual)
First posted: 28 May 2012 (estimated)
Results: Posted 23 Feb 2016

Clinical summary

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

Detailed description

Study design

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

Arm	Type	Receives
44 Weeks of PEG-IFN alfa-2b + RBV	Experimental	Drug: PEG-IFN alfa-2b, Drug: ribavirinParticipants achieving RVR at 4 weeks of treatment will receive 44 additional weeks of Peg-IFN Alfa-2b + RBV.
20 Weeks of PEG-IFN alfa-2b + RBV	Experimental	Drug: PEG-IFN alfa-2b, Drug: ribavirinParticipants achieving RVR at 4 weeks of treatment will receive 20 additional weeks of Peg-IFN Alfa-2b + RBV.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Participant is ≥40 kg and ≤120 kg weight
Participant and participant'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 medication, or longer if dictated by local regulations.
Previously documented CHC genotype 4 infection
Liver biopsy or fibrotest and fibroscan with histology consistent with CHC and no other etiology and with hepatic fibrosis scores (F0, F1, F2, F3).

Key exclusion criteria (10 listed)

Co-infected with the human immunodeficiency virus (HIV) or hepatitis B virus
Treatment for hepatitis C with any investigational medication
Treatment with any investigational drug within 30 days of the screening visit
Evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy
Autoimmune hepatitis or a history of autoimmune disease

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
PEG-IFN alfa-2bPegylated interferon alfa-2b administered subcutaneously 1.5 mcg/kg/week	Drug	20 Weeks of PEG-IFN alfa-2b + RBV, 44 Weeks of PEG-IFN alfa-2b + RBV
ribavirinRibavirin 200 mg capsules administered orally daily based on weight	Drug	20 Weeks of PEG-IFN alfa-2b + RBV, 44 Weeks of PEG-IFN alfa-2b + RBV

Primary outcome

Number of Participants Achieving Sustained Virologic Response (SVR)
Time frame: At 24 weeks after the completion of therapy (up to 72 weeks)
SVR was defined as undetectable HCV RNA levels 24 weeks after the completion of therapy.

Results and safety

Results posted to the registry on 23 Feb 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
44 Weeks of PEG-IFN Alfa-2b + RBV	22	17
20 Weeks of PEG-IFN Alfa-2b + RBV	23	21

Primary outcome: Number of Participants Achieving Sustained Virologic Response (SVR)

Time frame: At 24 weeks after the completion of therapy (up to 72 weeks). Number. Unit: Participants

Measure	44 Weeks of PEG-IFN Alfa-2b + RBV n = 22	20 Weeks of PEG-IFN Alfa-2b + RBV n = 23
Value	13	22

Population analysed: All Treated Population, which included all participants who received at least one dose of study medication after RVR.

Adverse events

Time frame: Up to 72 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
44 Weeks of PEG-IFN Alfa-2b + RBV	0 of 22 (0%)	16 of 22 (72.7%)	Not reported
20 Weeks of PEG-IFN Alfa-2b + RBV	2 of 23 (8.7%)	13 of 23 (56.5%)	Not reported

Limitations and caveats (from the sponsor): This Trial was prematurely terminated due to the availability of more promising treatment for HCV participants and the change in treatment guidelines, which will offer the patient a better treatment opportunity.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Related trials for Hepatitis C, Chronic

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
Autoimmune Diseases, Lupus Erythematosus, Systemic

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.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing PEG-IFN alfa-2b and ribavirin 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 4 inclusion and 10 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 25 Oct 2018. 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 23 Feb 2016). 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 Achieving Sustained Virologic Response (SVR) (time frame: At 24 weeks after the completion of therapy (up to 72 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 NCT01606800.

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 25 Oct 2018.