Hepatitis C, ChronicPhase 4NCT00687544

Efficacy and Safety of PegIntron Plus Ribavirin for Treatment of Chronic Hepatitis C in HIV-Infected Subjects (Study P04469)(TERMINATED)

A Phase 4 study testing Peginterferon alfa-2b (SCH 054031) and Ribavirin (SCH 018908) in people with Hepatitis C, Chronic and Hepacivirus, run by Merck Sharp & Dohme LLC.

Terminated

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Hepatitis C, Chronic, Hepacivirus, HIV Infections
What is being tested?: Peginterferon alfa-2b (SCH 054031) and Ribavirin (SCH 018908)
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 11 participants
Where: No sites listed yet
Study dates: Dec 2005to Sep 2008
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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Previously untreated chronic hepatitis C with HCV-RNA positive in plasma.
Must have finished the detoxification phase of a drug rehabilitation program and abstained for at least 6 weeks from using abused substance (alcohol, I.V. drugs and inhaled drugs) before starting therapy.
Liver transaminases (alanine aminotransferase [ALT]) 1.5-fold above the upper limit of normal.
Controlled HIV infection with a viral load <10,000 copies/mL and a CD4 cell (T-cell) count >200 x 10^6 cells/L, in response to a stable antiretroviral treatment (ART) or without ART if it is not required.
Compensated liver disease with protocol-specified minimum hematologic, biochemical, and serologic criteria at the Entry visit.
Alpha-fetoprotein value within normal limits obtained within one year prior to entry. Results above the upper limit of normal but <=50 ng/mL require both of the following: Alpha-fetoprotein value <=50 ng/mL obtained within 3 months prior to entry in the study and Ultrasound obtained within 3 months prior to entry in the study or that is negative for evidence of hepatocellular carcinoma.

Show all 10Show fewer

Liver biopsy (optional) within 12 months prior to study entry with a pathology report confirming that the histologic diagnosis is consistent with chronic hepatitis.
Women of childbearing potential must be using an acceptable method of birth control or be surgically sterilized.
Reconfirmation that sexually active males must be practicing acceptable methods of contraception during the treatment period and for 6 months after discontinuation of therapy.
Subjects must be free of any clinically significant diseases other than hepatitis or HIV infection that would interfere with study evaluations.

Who cannot join

Suspected hypersensitivity to interferon, PEG-interferon, or ribavirin.
HIV therapy using didanosine (ddI) and stavudine (d4T) in their HIV medications, due to the potentiality of the resulting lactic acidosis.
Participation in any other clinical trial within 30 days of entry to this protocol.
Treatment with any investigational drug within 30 days of entry to this protocol.
Subjects with organ transplants other than cornea and hair transplant.
Any cause for the liver disease based on subject history and biopsy (where applicable) other than chronic hepatitis C, including but not limited to coinfection with hepatitis B virus (HBV); hemochromatosis (iron deposition >2+ in liver parenchyma); alpha-1 antitrypsin deficiency; Wilson's disease; autoimmune hepatitis; alcoholic liver disease; obesity-induced liver disease.

Show all 20Show fewer

Hemophilia or any other condition that would prevent the subject from having a liver biopsy, including anticoagulant therapy.
Hemoglobinopathies (eg, Thalassemia)
Evidence of advanced liver disease such as history or presence of ascites, bleeding varices, and encephalopathy.
Any known preexisting medical condition that could interfere with the subject's participation in and completion of the protocol such as preexisting psychiatric condition, especially severe depression, or a history of severe psychiatric disorder.
Significant cardiovascular dysfunction within the past 6 months (eg, angina, congestive heart failure, recent myocardial infarction, severe hypertension, or significant arrhythmia). Subjects with electrocardiogram (ECG) showing clinically significant abnormalities.
Poorly controlled diabetes mellitus.
Chronic pulmonary disease (eg, chronic obstructive pulmonary disease).
Immunologically mediated disease.
Any medical condition requiring, or likely to require during the course of the study, chronic systemic administration of steroids.
Clinical gout.
Clinically significant retinal abnormalities.
Alcohol consumption of >20 gr/day.
Women who are pregnant or nursing.
Subjects who have not observed the designated washout periods for any of the prohibited medications.

About this study

Official title: Efficacy and Safety of PegIntron Plus Ribavirin for Treatment of Chronic Hepatitis C Infection in HIV-Infected Persons Not Previously Treated With Interferon

In this study, adult Indonesian subjects with human immunodeficiency virus (HIV) coinfected with chronic hepatitis C (CHC) will be given peginterferon alfa-2b (PEG-IFN) plus ribavirin (RBV) combination therapy. The efficacy rate (sustained virologic response, end of treatment virologic response, and sustained biochemical response), the subject morbidity rate as caused by other opportunistic infection (eg, bacterial pneumonia, tuberculosis, and other bacterial infection), and the safety and tolerability of this combination therapy will be examined.

Conditions: Hepatitis C, Chronic, Hepacivirus, HIV Infections
Being tested: Peginterferon alfa-2b (SCH 054031), Ribavirin (SCH 018908)
Keywords: HIV
Medical subject headings: Hepatitis C, Chronic, HIV Infections

What participants receive

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

Peginterferon alfa-2b (SCH 054031)Biological
Also called PegIntron
Subjects will be given peginterferon alfa-2b (PEG-IFN) subcutaneously, at a dose of 1.5 ug/kg weekly. Treatment duration will be 48 weeks for subjects with Hepatitis C Virus (HCV) genotype 1 and 24 weeks for subjects with HCV genotype 2 or 3 and baseline Hepatitis C Virus-ribonucleic acid (HCV-RNA) below 800,000 IU/mL.
Ribavirin (SCH 018908)Drug
Also called Rebetol
Subjects will be given ribavirin 800 mg/day orally(PO) when body weight is <65 kg, 1000 mg/day when body weight is between 65 kg and 85 kg, and 1200 mg/day when body weight is >85 kg. Treatment duration will be 48 weeks for subjects with HCV genotype 1 and 24 weeks for subjects with HCV genotype 2 or 3 and baseline HCV-RNA below 800,000 IU/mL.

Study groups in NCT00687544
Study group	Role	What they receive
PEG-IFN + RBV	Experimental	PEG-IFN + RBV therapy in previously untreated chronic HCV subjects coinfected with HIV Receives: Biological: Peginterferon alfa-2b (SCH 054031); Drug: Ribavirin (SCH 018908)

What is being measured

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

Number of Participants Who Achieved Sustained Virologic Response (SVR)
Treatment duration for genotype 1 participants was 48 weeks. Treatment duration for genotypes 2 \& 3 participants who had baseline hepatitis c virus ribonucleic acid [HCV-RNA] <800,000 IU/mL was 24 weeks.
SVR was defined as plasma HCV RNA level below lower level of quanitation at the end of 24 weeks follow-up (week 48 or 72).
The study was terminated due to low enrollment. This analysis was not performed.
Measured: Week 48 or Week 72 (depending on duration of treatment)
Number of Participants Who Achieved Virologic Response (VR)
Treatment duration for genotype 1 participants was 48 weeks. Treatment duration for genotypes 2 \& 3 participants who had baseline hepatitis c virus ribonucleic acid [HCV-RNA] <800,000 IU/mL was 24 weeks.
The study was terminated due to low enrollment. This analysis was not performed.
Measured: 24 Weeks or 48 Weeks (depending on duration of treatment, which was either 24 or 48 weeks)
Number of Participants Who Achieved Sustained Biochemical Response (SBR)
Treatment duration for genotype 1 participants was 48 weeks. Treatment duration for genotypes 2 \& 3 participants who had baseline hepatitis c virus ribonucleic acid [HCV-RNA] <800,000 IU/mL was 24 weeks.
SBR was defined as the presence of normal alanine aminotransferase (ALT) values at the end of 24 weeks follow-up (week 48 or 72).
The study was terminated due to low enrollment. This analysis was not performed.
Measured: Week 48 or Week 72 (depending on duration of treatment, which was either 24 or 48 weeks)

Secondary outcomes (3)

Number of Participants Experiencing Opportunistic Infection
The study was terminated due to low enrollment. This analysis was not performed.
Measured: Throughout the study (up to 72 weeks)
Number of Participants Who Died
Measured: Throughout the study (up to 72 weeks)
Number of Participants Experiencing Adverse Events
An adverse event was defined as any untoward medical occurrence in a subject administered a pharmaceutical product, biologic (at any dose), or medical device, which did not necessarily have a causal relationship with the treatment.
Measured: Throughout the study (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.

Dec 2005Sep 2008

First posted30 May 2008 (estimated)
Study startDec 2005
Primary completionSep 2008
Study completionSep 2008

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00687544
Sponsor's protocol ID: P04469
Status last verified: Mar 2017
First submitted: 27 May 2008
Last updated: 6 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
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

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 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of PegIntron Plus Ribavirin for Treatment of Chronic Hepatitis C Infection in HIV-Infected Persons Not Previously Treated With Interferon
ClinicalTrials.gov ID: NCT00687544
Acronym / sponsor ID: P04469
Conditions: Hepatitis C, Chronic, Hepacivirus, HIV Infections
Keywords: HIV
Phase: Phase 4
Study type: Interventional
Recruitment status: Terminated
Enrolment: 11 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Dec 2005
Primary completion: Sep 2008 (actual)
Study completion: Sep 2008 (actual)
First posted: 30 May 2008 (estimated)
Results: Posted 30 Jan 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
PEG-IFN + RBV	Experimental	Biological: Peginterferon alfa-2b (SCH 054031), Drug: Ribavirin (SCH 018908)PEG-IFN + RBV therapy in previously untreated chronic HCV subjects coinfected with HIV

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Previously untreated chronic hepatitis C with HCV-RNA positive in plasma.
Must have finished the detoxification phase of a drug rehabilitation program and abstained for at least 6 weeks from using abused substance (alcohol, I.V. drugs and inhaled drugs) before starting therapy.
Liver transaminases (alanine aminotransferase [ALT]) 1.5-fold above the upper limit of normal.
Controlled HIV infection with a viral load <10,000 copies/mL and a CD4 cell (T-cell) count >200 x 10^6 cells/L, in response to a stable antiretroviral treatment (ART) or without ART if it is not required.
Compensated liver disease with protocol-specified minimum hematologic, biochemical, and serologic criteria at the Entry visit.

Key exclusion criteria (20 listed)

Suspected hypersensitivity to interferon, PEG-interferon, or ribavirin.
HIV therapy using didanosine (ddI) and stavudine (d4T) in their HIV medications, due to the potentiality of the resulting lactic acidosis.
Participation in any other clinical trial within 30 days of entry to this protocol.
Treatment with any investigational drug within 30 days of entry to this protocol.
Subjects with organ transplants other than cornea and hair transplant.

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 (SCH 054031)Also: PegIntronSubjects will be given peginterferon alfa-2b (PEG-IFN) subcutaneously, at a dose of 1.5 ug/kg weekly. Treatment duration will be 48 weeks for subjects with Hepatitis C Virus (HCV) genotype 1 and 24 weeks for subjects with HCV genotype 2 or 3 and baseline Hepatitis C Virus-ribonucleic acid (HCV-RNA) below 800,000 IU/mL.	Biological	PEG-IFN + RBV
Ribavirin (SCH 018908)Also: RebetolSubjects will be given ribavirin 800 mg/day orally(PO) when body weight is <65 kg, 1000 mg/day when body weight is between 65 kg and 85 kg, and 1200 mg/day when body weight is >85 kg. Treatment duration will be 48 weeks for subjects with HCV genotype 1 and 24 weeks for subjects with HCV genotype 2 or 3 and baseline HCV-RNA below 800,000 IU/mL.	Drug	PEG-IFN + RBV

Primary outcome

Number of Participants Who Achieved Sustained Virologic Response (SVR)
Time frame: Week 48 or Week 72 (depending on duration of treatment)
Treatment duration for genotype 1 participants was 48 weeks. Treatment duration for genotypes 2 \& 3 participants who had baseline hepatitis c virus ribonucleic acid [HCV-RNA] <800,000 IU/mL was 24 weeks. SVR was defined as plasma HCV RNA level below lower level of quanitation at the end of 24 weeks follow-up (week 48 or 72). The study was terminated due to low enrollment. This analysis was not performed.
Number of Participants Who Achieved Virologic Response (VR)
Time frame: 24 Weeks or 48 Weeks (depending on duration of treatment, which was either 24 or 48 weeks)
Treatment duration for genotype 1 participants was 48 weeks. Treatment duration for genotypes 2 \& 3 participants who had baseline hepatitis c virus ribonucleic acid [HCV-RNA] <800,000 IU/mL was 24 weeks. The study was terminated due to low enrollment. This analysis was not performed.
Number of Participants Who Achieved Sustained Biochemical Response (SBR)
Time frame: Week 48 or Week 72 (depending on duration of treatment, which was either 24 or 48 weeks)
Treatment duration for genotype 1 participants was 48 weeks. Treatment duration for genotypes 2 \& 3 participants who had baseline hepatitis c virus ribonucleic acid [HCV-RNA] <800,000 IU/mL was 24 weeks. SBR was defined as the presence of normal alanine aminotransferase (ALT) values at the end of 24 weeks follow-up (week 48 or 72). The study was terminated due to low enrollment. This analysis was not performed.

3 secondary outcomes

Number of Participants Experiencing Opportunistic Infection
Time frame: Throughout the study (up to 72 weeks)
Number of Participants Who Died
Time frame: Throughout the study (up to 72 weeks)
Number of Participants Experiencing Adverse Events
Time frame: Throughout the study (up to 72 weeks)

Results and safety

Results posted to the registry on 30 Jan 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
PEG-IFN + RBV	11	0

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

Time frame: Week 48 or Week 72 (depending on duration of treatment)

Primary outcome: Number of Participants Who Achieved Virologic Response (VR)

Time frame: 24 Weeks or 48 Weeks (depending on duration of treatment, which was either 24 or 48 weeks)

Primary outcome: Number of Participants Who Achieved Sustained Biochemical Response (SBR)

Time frame: Week 48 or Week 72 (depending on duration of treatment, which was either 24 or 48 weeks)

3 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
PEG-IFN + RBV	1 of 11 (9.1%)	10 of 11 (90.9%)	Not reported

Limitations and caveats (from the sponsor): The study was terminated early due to low enrollment. The primary and secondary outcomes were not evaluated. A formal safety analysis was not performed for the 11 participants enrolled in the study.

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

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.

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 4 study testing Peginterferon alfa-2b (SCH 054031) and Ribavirin (SCH 018908) in people with Hepatitis C, Chronic and Hepacivirus, 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 10 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: 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 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 30 Jan 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 Who Achieved Sustained Virologic Response (SVR) (time frame: Week 48 or Week 72 (depending on duration of treatment)). The study lists 3 primary outcomes in all. 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 NCT00687544.

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.