Chronic Hepatitis CNCT00736242
Post-marketing Surveillance of HIV-infected Patients With Chronic Hepatitis C Treated With PegIntron Pen and Rebetol (Study P04584)
An observational study of Chronic Hepatitis C and Hepatitis C, run by Merck Sharp & Dohme LLC.
Trial summary
The objective of the study was to assess the safety and efficacy of peginterferon alfa-2b (PEG-IFN alfa-2b) and ribavirin (RBV) administered to participants coinfected with Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis C, Hepatitis C, HIV Infections
- What is being tested?
- PEG-IFN alfa-2b and RBV
- Type of treatment
- Injection or infusion
- How many people
- 232 participants
- Where
- No sites listed yet
- Study dates
- Dec 2005to Dec 2011
- 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: Subjects coinfected with HIV and HCV seen in common medical practice by general practitioners and clinical doctors at 30 sites all over Germany.
Who may be able to join
- ≥ 18 years of age eligible for treatment according to the Summary of Product Characteristics (SmPC)
- Presence of chronic Hepatitis C (with elevated liver enzymes and without decompensation)
- Presence of HCV-RNA and known genotype of the infecting hepatitis C virus
- HIV infection confirmed by positive Enzyme Linked Immunosorbent Assay (ELISA) and Western blot and Cluster of differentiation (CD) 4 cell count >200/mL
- Treatment-naïve
- Platelets ≥ 75,000/mm^3
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- Neutrophil counts ≥ 1,500/mm^3
- Thyroid Stimulating Hormone (TSH) must be within normal limits
- Hemoglobin ≥ 10 g/dL (females); ≥ 11 g/dL (males)
- Women of childbearing potential must have a routine pregnancy test performed monthly during treatment and for 7 months thereafter. Sexually active female participants of childbearing potential must be practicing adequate contraception (intrauterine device, oral contraceptives, implanted contraceptives, surgical sterilization, barrier method, or monogamous relationship with a male partner who has had a vasectomy or is using a condom (+ spermicide) during the treatment period and for 7 months after stopping treatment.
- Sexually active male participants must be practicing acceptable methods of contraception (vasectomy, use of condom + spermicide, monogamous relationship with a female partner who practices an acceptable method of contraception) during the treatment period and for 7 months after stopping treatment.
Who cannot join
- Contraindications according to the European approval and to the SmPC
- Pretreatment of chronic hepatitis C
- Liver decompensation
- Hypersensitivity to the active substance or to any interferons or to any of the excipients
- Pregnant woman
- Women who are breast feeding
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- Existence of or history of psychiatric condition, particular depression, suicidal ideation or suicide attempt
- A history of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous six months
- Severe debilitating medical conditions, including participants with chronic renal failure or creatinine clearance < 50 ml/min.
- 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: Treatment of Chronic Hepatitis C in HIV-infected Patients With PegIntron Pen and Rebetol According to German Law (§ 67 Abs 6 AMG)
The objective of the study was to assess the safety and efficacy of peginterferon alfa-2b (PEG-IFN alfa-2b) and ribavirin (RBV) administered to participants coinfected with Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV). Participants were treated by general practitioners in clinical practice as part of the post-marketing surveillance study. The study assessed the rates of eradication of the HCV and the rates of serious adverse events reported with PEG-IFN alfa-2b (1.5 ug/kg/week) and RBV (800-1200 mg/day) in common medical practice in Germany.
Read the detailed description
In this observational, non-interventional study, the time of enrollment and start of treatment was the sole decision of the physician. No investigational medicinal product was provided by the sponsor.
- Conditions
- Chronic Hepatitis C, Hepatitis C, HIV Infections
- Being tested
- PEG-IFN alfa-2b, RBV
- Keywords
- HIV
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis C, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-IFN alfa-2bBiological
Also called SCH 054031, PegIntron
Peginterferon alfa-2b administered subcutaneously at a dose 1.5 ug/kg/week, according to the European Medicines Agency (EMEA)-approved labeling
RBVDrug
Also called Rebetol, SCH 018908
Ribavirin administered at a dose of 800-1200 mg/day (on a weight-basis) according to the EMEA-approved labeling
| Study group | Role | What they receive |
|---|---|---|
| PEG-IFN alfa-2b + RBV | Participants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor. Receives: Biological: PEG-IFN alfa-2b; Drug: RBV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Sustained Virologic Response (SVR)
SVR was defined as undetectable serum Hepatitis C Virus ribonucleic acid (HCV-RNA) at End of Treatment (EOT) and at the End of Follow-up (EOF).
Measured: From End of Treatment to 24 weeks post-treatment (up to 72 weeks)
Secondary outcomes (7)
Number of Participants With Rapid Virologic Response (RVR)
RVR was defined as undetectable serum HCV-RNA at week 4.
Measured: At Treatment Week 4
Number of Participants With Early Virologic Response (EVR)
EVR was defined as undetectable serum HCV-RNA at week 12 and/or a
≥2 log decline in HCV-RNA levels at week 12 from baseline.
Measured: From Treatment Week 1 to Treatment Week 12
Participant Study Status at End of Follow-up (EOF)
Participant study status was assessed at the End of Follow-up (defined as 24 weeks after the end of treatment) based on serum levels of HCV-RNA.
SVR was defined as defined as undetectable serum HCV-RNA at EOT and EOF, Relapse was defined as undetectable HCV-RNA at EOT with detectable HCV-RNA at EOF, and Non-response was defined as a detectable serum HCV-RNA at EOT.
Measured: From EOT to EOF (up to 72 weeks)
Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
HCV-RNA negativity/positivity was documented at baseline in the medical history (anamnesis), and assessed within the laboratory (lab) at baseline and during treatment by Polymerase Chain Reaction (PCR).
HCV-RNA (+) = HCV-RNA positive, HCV-RNA (-) = HCV-RNA negative, HCV-RNA Missing = HCV-RNA data not documented, not applicable, not known, not examined, or missing.
Measured: From the Baseline Visit up to EOF (up to 72 weeks)
Number of Participants With Human Immunodeficiency Virus (HIV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
HIV-RNA negativity/positivity was documented at baseline in the medical history (anamnesis), and assessed within the laboratory (lab) at baseline and during treatment.
HIV-RNA (+) = HIV-RNA positive, HIV-RNA (-) = HIV-RNA negative, HIV-RNA Missing = HIV-RNA data not documented, not applicable, not known, not examined, or missing
Measured: From the Baseline Visit up to EOF (up to 72 weeks)
Median Cluster of Differentiation 4 (CD4) Cell Count During PEG-IFN Alfa-2b/RBV Treatment
The CD4 helper T cell count was used to assess participant HIV status and was determined in the laboratory at baseline and during the study course.
Measured: From the Baseline Visit up to EOF (up to 72 weeks)
Number of Participants With A Serious Adverse Event (SAE) During PEG-IFN Alfa-2b/RBV Treatment
An SAE was any adverse drug/biologic/device experience occurring at any dose that resulted in death, was life-threatening (i.e. placed the participant, in the view of the initial reporter, at immediate risk of death from the AE as it occurred), was a persistent or significant disability/incapacity, required in-patient hospitalization, or prolonged hospitalization, or led to a
congenital anomaly or birth defect.
Measured: From First Participant Visit (12/30/2005) up to 30 days after Last Participant Visit (12/31/2011).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2008 (estimated)
- Study startDec 2005
- Primary completionDec 2011
- Study completionDec 2011
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 Chronic Hepatitis CStudies 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
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00736242
- Sponsor's protocol ID
- P04584
- Status last verified
- Feb 2015
- First submitted
- 30 Jul 2008
- Last updated
- 19 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Chronic Hepatitis C in HIV-infected Patients With PegIntron Pen and Rebetol According to German Law (§ 67 Abs 6 AMG)
- ClinicalTrials.gov ID
- NCT00736242
- Acronym / sponsor ID
- P04584
- Conditions
- Chronic Hepatitis C, Hepatitis C, HIV Infections
- Keywords
- HIV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 15 Aug 2008 (estimated)
- Results
- Posted 8 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study was to assess the safety and efficacy of peginterferon alfa-2b (PEG-IFN alfa-2b) and ribavirin (RBV) administered to participants coinfected with Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV). Participants were treated by general practitioners in clinical practice as part of the post-marketing surveillance study. The study assessed the rates of eradication of the HCV and the rates of serious adverse events reported with PEG-IFN alfa-2b (1.5 ug/kg/week) and RBV (800-1200 mg/day) in common medical practice in Germany.
Detailed description
In this observational, non-interventional study, the time of enrollment and start of treatment was the sole decision of the physician. No investigational medicinal product was provided by the sponsor.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PEG-IFN alfa-2b + RBV | – | Biological: PEG-IFN alfa-2b, Drug: RBVParticipants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects coinfected with HIV and HCV seen in common medical practice by general practitioners and clinical doctors at 30 sites all over Germany.
Key inclusion criteria (11 listed)
- ≥ 18 years of age eligible for treatment according to the Summary of Product Characteristics (SmPC)
- Presence of chronic Hepatitis C (with elevated liver enzymes and without decompensation)
- Presence of HCV-RNA and known genotype of the infecting hepatitis C virus
- HIV infection confirmed by positive Enzyme Linked Immunosorbent Assay (ELISA) and Western blot and Cluster of differentiation (CD) 4 cell count >200/mL
- Treatment-naïve
Key exclusion criteria (13 listed)
- Contraindications according to the European approval and to the SmPC
- Pretreatment of chronic hepatitis C
- Liver decompensation
- Hypersensitivity to the active substance or to any interferons or to any of the excipients
- Pregnant woman
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-2bAlso: SCH 054031, PegIntronPeginterferon alfa-2b administered subcutaneously at a dose 1.5 ug/kg/week, according to the European Medicines Agency (EMEA)-approved labeling | Biological | PEG-IFN alfa-2b + RBV |
| RBVAlso: Rebetol, SCH 018908Ribavirin administered at a dose of 800-1200 mg/day (on a weight-basis) according to the EMEA-approved labeling | Drug | PEG-IFN alfa-2b + RBV |
Primary outcome
Number of Participants With Sustained Virologic Response (SVR)
Time frame: From End of Treatment to 24 weeks post-treatment (up to 72 weeks)
SVR was defined as undetectable serum Hepatitis C Virus ribonucleic acid (HCV-RNA) at End of Treatment (EOT) and at the End of Follow-up (EOF).
7 secondary outcomes
Number of Participants With Rapid Virologic Response (RVR)
Time frame: At Treatment Week 4
Number of Participants With Early Virologic Response (EVR)
Time frame: From Treatment Week 1 to Treatment Week 12
Participant Study Status at End of Follow-up (EOF)
Time frame: From EOT to EOF (up to 72 weeks)
Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Time frame: From the Baseline Visit up to EOF (up to 72 weeks)
Number of Participants With Human Immunodeficiency Virus (HIV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Time frame: From the Baseline Visit up to EOF (up to 72 weeks)
Median Cluster of Differentiation 4 (CD4) Cell Count During PEG-IFN Alfa-2b/RBV Treatment
Time frame: From the Baseline Visit up to EOF (up to 72 weeks)
Number of Participants With A Serious Adverse Event (SAE) During PEG-IFN Alfa-2b/RBV Treatment
Time frame: From First Participant Visit (12/30/2005) up to 30 days after Last Participant Visit (12/31/2011).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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?
An observational study of Chronic Hepatitis C and Hepatitis C, 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: finished, as of the sponsor's last update on 19 Feb 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 8 Apr 2013). 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 Sustained Virologic Response (SVR) (time frame: From End of Treatment to 24 weeks post-treatment (up to 72 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Feb 2015.