Hepatitis C, ChronicSUPPORTNCT00726557

Post-marketing Surveillance Study of Ex-intravenous Drug Abusers With Chronic Hepatitis C Treated With PegIntron Plus Rebetol (P04408/MK-4031-261)

An observational study of Hepatitis C, Chronic and Substance Abuse, Intravenous, 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

Who is it for?: Ages 18 years and older
Conditions the study is for: Hepatitis C, Chronic, Substance Abuse, Intravenous
What is being tested?: PegIntron (pegylated interferon alfa-2b; SCH 54031) and Rebetol (ribavirin; SCH 18908)
How many people: 246 participants
Where: No sites listed yet
Study dates: Oct 2005to Jan 2009
Phase: Observational
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

Study population: Previous intravenous drug abusers with chronic hepatitis C receiving substitution therapy (buprenorphine, methadone or other) at approximately 100 sites in Germany.

Who may be able to join

Treatment-naïve participants or relapsers to interferon monotherapy
Participants with chronic hepatitis C infection
At least 18 years of age
Must meet the following laboratory criteria:
Platelets >=100,000/mm^3
Neutrophil count >=1,500/mm^3

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TSH (thyroid stimulating hormone) within normal limits
Hemoglobin >=12 g/dL (females); >=13 g/dL (males)
Ex-intravenous drug abusers who are under stable substitution therapy
Women of childbearing potential must practice adequate contraception and have a routine pregnancy test performed monthly during treatment and for 7 months post-treatment.
Sexually-active participants must be practicing acceptable methods of contraception during the treatment and for 7 months post-treatment

Who cannot join

Any contraindications specified in the SPC (Summary of Product Characteristics) and approved European labeling
Hypersensitivity to the active substance or to any interferons or to any of the excipients
Pregnant women
Women who are breast-feeding
Existence of or history of severe psychiatric condition, in particular severe depression, suicidal ideation or suicide attempt
A history of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous 6 months

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Severe debilitating medical conditions, including participants with chronic renal failure or creatinine clearance <50 mL/min
Coinfection with HIV (Human Immunodeficiency Virus)
Autoimmune hepatitis or history of autoimmune disease
Severe hepatic dysfunction or decompensated cirrhosis of the liver
Pre-existing thyroid disease unless it can be controlled with conventional therapy
Epilepsy and/or compromised central nervous system function

About this study

Official title: Quality Assurance of HCV-therapy With PegIntron® Plus Rebetol® in Drug-substituted Patients - SUPPORT Project Post-Marketing Surveillance Study

Previous intravenous drug abusers with chronic hepatitis C who are under substitution therapy (buprenorphine, methadone) will be treated with PegIntron and Rebetol according to the approved European labeling. The study will assess the tolerability, safety and efficacy of the treatment with PegIntron plus Rebetol in this study population. The objective of the study is to collect data on the prevalence of the hepatitis C infections in drug-substituted patients. The study will also compare the feasibility of HCV (Hepatitis C Virus) treatment in patients receiving Subutex® vs other drug substitution pharmacotherapies.

Conditions: Hepatitis C, Chronic, Substance Abuse, Intravenous
Being tested: PegIntron (pegylated interferon alfa-2b; SCH 54031), Rebetol (ribavirin; SCH 18908)
Medical subject headings: Hepatitis C, Chronic, Substance Abuse, Intravenous

What participants receive

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

PegIntron (pegylated interferon alfa-2b; SCH 54031)Biological
Also called SCH 54031
PegIntron 1.5 μg/kg/week administered for a minimum of 12 weeks. Patients who achieve early virologic response at Treatment Week 12, will continue PegIntron therapy for a total of 24 weeks for subjects infected with HCV genotype 2 or 3, and for a total of 48 weeks for subjects infected with HCV genotype 1 or 4
Rebetol (ribavirin; SCH 18908)Drug
Also called SCH 18908
Rebetol administered at 10.6 mg/kg/day for a minimum of 12 weeks. Patients who achieve early virologic response at Treatment Week 12, will continue Rebetol therapy for a total of 24 weeks for subjects infected with HCV genotype 2 or 3, and for a total of 48 weeks for subjects infected with HCV genotype 1 or 4

Study groups in NCT00726557
Study group	Role	What they receive
PegIntron + Rebetol		There will be a distinction between the patients depending on the type of substitution drug used (secondary parameters). Receives: Biological: PegIntron (pegylated interferon alfa-2b; SCH 54031); Drug: Rebetol (ribavirin; SCH 18908)

What is being measured

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

Number of Drug-substituted Participants Who Achieved Sustained Virological Response (SVR) With PegIntron 1.5 μg/kg/Week and Rebetol (10.6 mg/kg/Day) in Substitution Centers Under Routine Conditions
Participants who achieved SVR (sustained virological response) at the end of treatment (24 weeks for genotypes 2,3 and 48 weeks for genotypes 1,4) were analyzed for sustained response at the end of the follow-up period (24 weeks after end of treatment). SVR is defined as having negative HCV-RNA (hepatitis C virus ribonucleic acid).
Measured: End of Follow-up (Week 48 or Week 72, depending on genotype)
Number of Participants Who Tolerated Treatment With PegIntron 1.5 mcg/kg/Week + Rebetol 10.6 mg/kg/Week
Tolerability of the treatment was measured by number of participants with complete treatment.
Measured: Assessed at the end of treatment

Timeline

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

Oct 2005Jan 2009

First posted1 Aug 2008 (estimated)
Study startOct 2005
Primary completionJan 2009
Study completionJan 2009

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: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 246 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00726557
Sponsor's protocol ID: P04408
Acronym: SUPPORT
Status last verified: Oct 2015
First submitted: 30 Jul 2008
Last updated: 9 Oct 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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 9 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Quality Assurance of HCV-therapy With PegIntron® Plus Rebetol® in Drug-substituted Patients - SUPPORT Project Post-Marketing Surveillance Study
ClinicalTrials.gov ID: NCT00726557
Acronym / sponsor ID: SUPPORT / P04408
Conditions: Hepatitis C, Chronic, Substance Abuse, Intravenous
Study type: Observational
Recruitment status: Completed
Enrolment: 246 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Oct 2005
Primary completion: Jan 2009 (actual)
Study completion: Jan 2009 (actual)
First posted: 1 Aug 2008 (estimated)
Results: Posted 17 May 2010

Clinical summary

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

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
PegIntron + Rebetol	–	Biological: PegIntron (pegylated interferon alfa-2b; SCH 54031), Drug: Rebetol (ribavirin; SCH 18908)There will be a distinction between the patients depending on the type of substitution drug used (secondary parameters).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Previous intravenous drug abusers with chronic hepatitis C receiving substitution therapy (buprenorphine, methadone or other) at approximately 100 sites in Germany.

Key inclusion criteria (11 listed)

Treatment-naïve participants or relapsers to interferon monotherapy
Participants with chronic hepatitis C infection
At least 18 years of age
Must meet the following laboratory criteria:
Ex-intravenous drug abusers who are under stable substitution therapy

Key exclusion criteria (12 listed)

Any contraindications specified in the SPC (Summary of Product Characteristics) and approved European labeling
Hypersensitivity to the active substance or to any interferons or to any of the excipients
Pregnant women
Women who are breast-feeding
Existence of or history of severe psychiatric condition, in particular severe depression, suicidal ideation or suicide attempt

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
PegIntron (pegylated interferon alfa-2b; SCH 54031)Also: SCH 54031PegIntron 1.5 μg/kg/week administered for a minimum of 12 weeks. Patients who achieve early virologic response at Treatment Week 12, will continue PegIntron therapy for a total of 24 weeks for subjects infected with HCV genotype 2 or 3, and for a total of 48 weeks for subjects infected with HCV genotype 1 or 4	Biological	PegIntron + Rebetol
Rebetol (ribavirin; SCH 18908)Also: SCH 18908Rebetol administered at 10.6 mg/kg/day for a minimum of 12 weeks. Patients who achieve early virologic response at Treatment Week 12, will continue Rebetol therapy for a total of 24 weeks for subjects infected with HCV genotype 2 or 3, and for a total of 48 weeks for subjects infected with HCV genotype 1 or 4	Drug	PegIntron + Rebetol

Primary outcome

Number of Drug-substituted Participants Who Achieved Sustained Virological Response (SVR) With PegIntron 1.5 μg/kg/Week and Rebetol (10.6 mg/kg/Day) in Substitution Centers Under Routine Conditions
Time frame: End of Follow-up (Week 48 or Week 72, depending on genotype)
Participants who achieved SVR (sustained virological response) at the end of treatment (24 weeks for genotypes 2,3 and 48 weeks for genotypes 1,4) were analyzed for sustained response at the end of the follow-up period (24 weeks after end of treatment). SVR is defined as having negative HCV-RNA (hepatitis C virus ribonucleic acid).
Number of Participants Who Tolerated Treatment With PegIntron 1.5 mcg/kg/Week + Rebetol 10.6 mg/kg/Week
Time frame: Assessed at the end of treatment
Tolerability of the treatment was measured by number of participants with complete treatment.

Results and safety

Results posted to the registry on 17 May 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PegIntron + Rebetol	246	118

Primary outcome: Number of Drug-substituted Participants Who Achieved Sustained Virological Response (SVR) With PegIntron 1.5 μg/kg/Week and Rebetol (10.6 mg/kg/Day) in Substitution Centers Under Routine Conditions

Time frame: End of Follow-up (Week 48 or Week 72, depending on genotype). Number. Unit: Participants

Measure	Participants With Negative HCV-RNA at End of Treatment n = 101
Opioid substitution with methadone (n=52)	49
Opioid substitution with levo-methadone (n=13)	10
Opioid substitution with buprenorphine (n=26)	23
Opioid substitution with other medication (n=1)	0
No opioid substitution medication (n=9)	9

Population analysed: Participants who achieved SVR at the end of treatment (24 weeks for genotypes 2,3 and 48 weeks for genotypes 1,4)

Primary outcome: Number of Participants Who Tolerated Treatment With PegIntron 1.5 mcg/kg/Week + Rebetol 10.6 mg/kg/Week

Time frame: Assessed at the end of treatment. Number. Unit: participants

Measure	Participants Who Tolerated Treatment n = 246
Value	118

Population analysed: All enrolled participants

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PegIntron + Rebetol	4 of 246 (1.6%)	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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?

An observational study of Hepatitis C, Chronic and Substance Abuse, Intravenous, 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 12 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 9 Oct 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 May 2010). 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 Drug-substituted Participants Who Achieved Sustained Virological Response (SVR) With PegIntron 1.5 μg/kg/Week and Rebetol (10.6 mg/kg/Day) in Substitution Centers Under Routine Conditions (time frame: End of Follow-up (Week 48 or Week 72, depending on genotype)). The study lists 2 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 NCT00726557.

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 9 Oct 2015.