Chronic Hepatitis CNCT01340573
Evaluating Safety and Efficacy In Hepatitis C Patients After PegIntron Pen Treatment (Study P04896)
An observational study of Chronic Hepatitis C, run by Merck Sharp & Dohme LLC.
Trial summary
This is a non-interventional study designed to evaluate the efficacy and safety of combination study drugs in the treatment of participants diagnosed with Chronic Hepatitis C (CHC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- PegIntron Pen and Ribavirin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 3 participants
- Where
- No sites listed yet
- Study dates
- 23 Mar 2007to 29 Oct 2007
- 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: Indonesian participants ≥18 years of age with confirmed chronic hepatitis C with HCV RNA positive in plasma.
Who may be able to join
- Demonstrate willingness to participate in the study and comply with its procedures by signing a written informed consent.
- Equal to or greater than 18 years.
- Confirmed chronic hepatitis C with hepatitis C virus (HCV) RNA positive in plasma.
- No previous use of PegIntron Pen.
Who cannot join
- Hypersensitivity to the active substance or to any interferon or to any of the excipients.
- Pregnant women.
- Women who are breastfeeding.
- Existence of or a history of severe psychiatric condition, particularly severe 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 condition, including patients with chronic renal failure or creatinine clearance < 50 ml/minute.
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- Auto immune hepatitis or a history of autoimmune disease.
- Severe hepatic dysfunction or decompensated cirrhosis of the liver.
- Pre-existing thyroid disease unless it can be controlled with conventional treatment.
- Epilepsy and/or compromised central nervous system (CNS) function.
About this study
Official title: Non-Interventional Study Evaluating The Safety and Efficacy In Patients Receiving New PegIntron Pen for Hepatitis C
This is a non-interventional study designed to evaluate the efficacy and safety of combination study drugs in the treatment of participants diagnosed with Chronic Hepatitis C (CHC). CHC participants with confirmed positive hepatitis-C virus (HCV) RNA in plasma, and who have not been previously treated with the Pegylated interferon (PegIntron) Pen, were enrolled into study.
Read the detailed description
Participants with positive genotype-1 HCV RNA received 48 weeks of treatment of PegIntron Pen plus ribavirin and 24 weeks of follow-up. Participants who were non-genotype-1 HCV RNA positive received 24 weeks of treatment of PegIntron Pen plus ribavirin and 24 weeks of follow-up. Participants were asked to complete a questionnaire to measure the satisfaction and the use of training materials of PegIntron pen using a 1-5 score system provided in the questionnaire. The questionnaire was completed once at first follow-up visit. Efficacy measurements for sustained viral response HCV RNA was collected at week-24 of treatment and at week-24 of follow-up in positive Non-genotype-1 HCV RNA participants. Efficacy measurements for sustained viral response HCV RNA was collected at week-24 and at week-48 of treatment, and at week-24 of follow-up, for positive Genotype-1 HCV RNA participants.
- Conditions
- Chronic Hepatitis C
- Being tested
- PegIntron Pen, Ribavirin
- Keywords
- Chronic Hepatitis C, pegylated interferon, PegIntron Pen, 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.
PegIntron PenDrug
Also called pegylated interferon Pen
Peginterferon alfa-2b, 1.5 microgram/kg each week, administered subcutaneously.
RibavirinDrug
Also called Ribasphere, Vilona, Copegus, Rebetol, Virazole
Dose is based on body weight. Each tablet of ribavirin is 200mg, and given by oral administration. Participants with body weight of <65 kg were administered 800 mg of ribavirin daily, body weight of 65 kg-85 kg received 1000 mg daily, and participants with a body weight of >85 kg received 1200 mg of ribavirin daily.
| Study group | Role | What they receive |
|---|---|---|
| Genotype 1 CHC Participants | Not described Receives: Drug: PegIntron Pen; Drug: Ribavirin | |
| Non-genotype 1 CHC participants | Not described Receives: Drug: PegIntron Pen; Drug: Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Genotype-1 Participants Who Experienced Serious Adverse Events (SAE) at Week-48 of Study Treatment
Collection of all safety reports (serious adverse events) from genotype-1 population at week-48 of treatment, from participants on pegylated interferon (PegIntron) pen plus ribavirin.
Measured: Week-48
Number of Genotype-1 Participants Who Experienced Serious Adverse Events (SAE) at Week-24 Follow-up
Collection of all safety reports (serious adverse events) from genotype-1 population at week-24 non-treatment follow-up, from participants on pegylated interferon (PegIntron) pen plus ribavirin.
Measured: Week-24 follow-up
Number of Non-genotype-1 Participants Who Experienced Serious Adverse Events (SAE) at Week-24 of Study Treatment
Collection of all safety reports (serious adverse events) from Non-genotype-1 population at week-24 of study treatment, from participants on pegylated interferon (PegIntron) pen plus ribavirin.
Measured: Week-24
Number of Non-genotype 1 Participants Who Experienced Serious Adverse Events (SAE) on Week-24 Follow-up
Collection of all safety reports (serious adverse events) from Non-genotype-1 population at week-24 non-treatment follow-up, from participants on pegylated interferon (PegIntron) pen plus ribavirin.
Measured: Week-24 follow-up
Secondary outcomes (5)
Number of Non-genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-24 of Study Treatment
Sustained virologic response (SVR) is the absence of detectable HCV RNA in serum after end of treatment.
Measured: Week-24
Number of Non-genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-24 Follow-up
Measured: Week-24 follow-up
Number of Genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-48 of Study Treatment
Measured: Week-48
Number of Genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-24 Follow-up
Measured: Week-24 follow-up
Participants' Overall Rating of Satisfaction and the Use of Training Materials for the Pegintron Pen, as Provided in a Study Questionnaire
Participants will complete a single questionnaire during the first follow-up visit (Week 12). The questionnaire will measure the participant's satisfaction and the use of training materials for the PegIntron Pen during the course of study therapy, as measured by the participant using a 1- 5 score system provided in the questionnaire.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2011 (estimated)
- Study start23 Mar 2007
- Primary completion29 Oct 2007
- Study completion29 Oct 2007
Why it stopped: Terminated early 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 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3 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
- NCT01340573
- Sponsor's protocol ID
- P04896
- Status last verified
- May 2024
- First submitted
- 18 Nov 2010
- Last updated
- 12 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Interventional Study Evaluating The Safety and Efficacy In Patients Receiving New PegIntron Pen for Hepatitis C
- ClinicalTrials.gov ID
- NCT01340573
- Acronym / sponsor ID
- P04896
- Conditions
- Chronic Hepatitis C
- Keywords
- Chronic Hepatitis C, pegylated interferon, PegIntron Pen, Ribavirin
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Terminated early due to low enrollment.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 23 Mar 2007 (actual)
- Primary completion
- 29 Oct 2007 (actual)
- Study completion
- 29 Oct 2007 (actual)
- First posted
- 22 Apr 2011 (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.
This is a non-interventional study designed to evaluate the efficacy and safety of combination study drugs in the treatment of participants diagnosed with Chronic Hepatitis C (CHC). CHC participants with confirmed positive hepatitis-C virus (HCV) RNA in plasma, and who have not been previously treated with the Pegylated interferon (PegIntron) Pen, were enrolled into study.
Detailed description
Participants with positive genotype-1 HCV RNA received 48 weeks of treatment of PegIntron Pen plus ribavirin and 24 weeks of follow-up. Participants who were non-genotype-1 HCV RNA positive received 24 weeks of treatment of PegIntron Pen plus ribavirin and 24 weeks of follow-up. Participants were asked to complete a questionnaire to measure the satisfaction and the use of training materials of PegIntron pen using a 1-5 score system provided in the questionnaire. The questionnaire was completed once at first follow-up visit. Efficacy measurements for sustained viral response HCV RNA was collected at week-24 of treatment and at week-24 of follow-up in positive Non-genotype-1 HCV RNA participants. Efficacy measurements for sustained viral response HCV RNA was collected at week-24 and at week-48 of treatment, and at week-24 of follow-up, for positive Genotype-1 HCV RNA participants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Genotype 1 CHC Participants | – | Drug: PegIntron Pen, Drug: Ribavirin |
| Non-genotype 1 CHC participants | – | Drug: PegIntron Pen, Drug: Ribavirin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Indonesian participants ≥18 years of age with confirmed chronic hepatitis C with HCV RNA positive in plasma.
Key inclusion criteria (4 listed)
- Demonstrate willingness to participate in the study and comply with its procedures by signing a written informed consent.
- Equal to or greater than 18 years.
- Confirmed chronic hepatitis C with hepatitis C virus (HCV) RNA positive in plasma.
- No previous use of PegIntron Pen.
Key exclusion criteria (10 listed)
- Hypersensitivity to the active substance or to any interferon or to any of the excipients.
- Pregnant women.
- Women who are breastfeeding.
- Existence of or a history of severe psychiatric condition, particularly severe 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.
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 PenAlso: pegylated interferon PenPeginterferon alfa-2b, 1.5 microgram/kg each week, administered subcutaneously. | Drug | Genotype 1 CHC Participants, Non-genotype 1 CHC participants |
| RibavirinAlso: Ribasphere, Vilona, Copegus, Rebetol, VirazoleDose is based on body weight. Each tablet of ribavirin is 200mg, and given by oral administration. Participants with body weight of <65 kg were administered 800 mg of ribavirin daily, body weight of 65 kg-85 kg received 1000 mg daily, and participants with a body weight of >85 kg received 1200 mg of ribavirin daily. | Drug | Genotype 1 CHC Participants, Non-genotype 1 CHC participants |
Primary outcome
Number of Genotype-1 Participants Who Experienced Serious Adverse Events (SAE) at Week-48 of Study Treatment
Time frame: Week-48
Collection of all safety reports (serious adverse events) from genotype-1 population at week-48 of treatment, from participants on pegylated interferon (PegIntron) pen plus ribavirin.
Number of Genotype-1 Participants Who Experienced Serious Adverse Events (SAE) at Week-24 Follow-up
Time frame: Week-24 follow-up
Collection of all safety reports (serious adverse events) from genotype-1 population at week-24 non-treatment follow-up, from participants on pegylated interferon (PegIntron) pen plus ribavirin.
Number of Non-genotype-1 Participants Who Experienced Serious Adverse Events (SAE) at Week-24 of Study Treatment
Time frame: Week-24
Collection of all safety reports (serious adverse events) from Non-genotype-1 population at week-24 of study treatment, from participants on pegylated interferon (PegIntron) pen plus ribavirin.
Number of Non-genotype 1 Participants Who Experienced Serious Adverse Events (SAE) on Week-24 Follow-up
Time frame: Week-24 follow-up
Collection of all safety reports (serious adverse events) from Non-genotype-1 population at week-24 non-treatment follow-up, from participants on pegylated interferon (PegIntron) pen plus ribavirin.
5 secondary outcomes
Number of Non-genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-24 of Study Treatment
Time frame: Week-24
Number of Non-genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-24 Follow-up
Time frame: Week-24 follow-up
Number of Genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-48 of Study Treatment
Time frame: Week-48
Number of Genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-24 Follow-up
Time frame: Week-24 follow-up
Participants' Overall Rating of Satisfaction and the Use of Training Materials for the Pegintron Pen, as Provided in a Study Questionnaire
Time frame: Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- 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, 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 12 Jun 2024. 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 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 Genotype-1 Participants Who Experienced Serious Adverse Events (SAE) at Week-48 of Study Treatment (time frame: Week-48). The study lists 4 primary outcomes in all. 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 12 Jun 2024.