Hepatitis C, ChronicNCT00727077
Post-marketing Surveillance of Children With Chronic Hepatitis C Treated With Intron A (Vial or Pen) and Rebetol (Study P04397)(TERMINATED)
An observational study of Hepatitis C, Chronic and Hepatitis C, run by Merck Sharp & Dohme LLC.
Trial summary
The objective of the study is to assess the safety and efficacy of Intron A (3 Mio I.E./m2, 3 times per week) and Rebetol (15 mg/kg/day) in children aged 3 to 17, treated in common medical practice at 10 sites in Germany. Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Hepatitis C, Chronic, Hepatitis C
- What is being tested?
- IntronA (interferon alfa-2b; SCH 30500) and Rebetol (ribavirin; SCH 18908)
- How many people
- 3 participants
- Where
- No sites listed yet
- Study dates
- Jun 2006to Jun 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
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 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children age 3 to 17 years, with chronic hepatitis C, treated in clinical practice at 10 German sites
Who may be able to join
- Patients with chronic hepatitis C (serum HCV-RNA-positive)
- Age 3 to 17 years
- Treatment-naïve
- Platelets >= 100,000/mm^3
- Neutrophil counts >= 1,500/ mm^3
- TSH must be within normal limits
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- Hemoglobin >=12 g/dL (females); >=13 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 subjects 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 subjects 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 SPC and European approval
- Pretreatment of chronic hepatitis C
- Liver decompensation
- Hypersensitivity to the active substance or to any interferons or to any of the excipients
- Pregnant woman
- Woman who are breast feeding
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- Existence of or history of psychiatric condition, in 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 patients with chronic renal failure or creatinine clearance < 50 mlLmin
- 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
- Individual decision of physician if patient suitable for treatment (e.g., disturbance of growth)
About this study
Official title: Treatment of Chronic Hepatitis C in Children With Intron Vial or Pen and Rebetol According to German Law (§ 67 Abs 6 AMG)
The objective of the study is to assess the safety and efficacy of Intron A (3 Mio I.E./m2, 3 times per week) and Rebetol (15 mg/kg/day) in children aged 3 to 17, treated in common medical practice at 10 sites in Germany. The primary objective is to determine if there are any new severe adverse events observed with this recently approved dosing regimen. The study will also evaluate the rates of eradication of the HCV virus.
This study was terminated due to low enrollment. At the time of termination, 3 participants had enrolled. Therefore, these 3 participants transferred into study P04538 (NCT00727077) and will be included in the P04538 (NCT00727077) data reporting.
- Conditions
- Hepatitis C, Chronic, Hepatitis C
- Being tested
- IntronA (interferon alfa-2b; SCH 30500), Rebetol (ribavirin; SCH 18908)
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IntronA (interferon alfa-2b; SCH 30500)Biological
Also called SCH 30500
IntronA (3 Mio I.E./m2, 3 times per week) administered in accordance with the SPC and approved European labeling
Rebetol (ribavirin; SCH 18908)Drug
Also called SCH 18908
Rebetol (15 mg/kg/day) administered in accordance with the SPC and approved European labeling
| Study group | Role | What they receive |
|---|---|---|
| IntronA/Rebetol | Children age 3 to 17, with chronic hepatitis C, treated in clinical practice at 10 German sites Receives: Biological: IntronA (interferon alfa-2b; SCH 30500); Drug: Rebetol (ribavirin; SCH 18908) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of serious adverse events
Measured: After the inclusion of the subject in the study (defined as the time when the subject signs the informed consent) and up to 30 days after the subject completed or discontinued the study
Secondary outcomes (1)
Sustained virologic response (defined as undetectable viral load at 24 weeks post-treatment)
Measured: Assessed at the end of treatment and 24 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2008 (estimated)
- Study startJun 2006
- Primary completionJun 2007
- Study completionJun 2007
Why it stopped: Study halted due to low recruitment. The 3 participants at time of termination transferred into study P04538 (NCT00727077). See NCT00727077 for details/results.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 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
- NCT00727077
- Sponsor's protocol ID
- P04397
- Status last verified
- Apr 2015
- First submitted
- 30 Jul 2008
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Chronic Hepatitis C in Children With Intron Vial or Pen and Rebetol According to German Law (§ 67 Abs 6 AMG)
- ClinicalTrials.gov ID
- NCT00727077
- Acronym / sponsor ID
- P04397
- Conditions
- Hepatitis C, Chronic, Hepatitis C
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study halted due to low recruitment. The 3 participants at time of termination transferred into study P04538 (NCT00727077). See NCT00727077 for details/results.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 1 Aug 2008 (estimated)
- Results
- Not posted in the source record
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 is to assess the safety and efficacy of Intron A (3 Mio I.E./m2, 3 times per week) and Rebetol (15 mg/kg/day) in children aged 3 to 17, treated in common medical practice at 10 sites in Germany. The primary objective is to determine if there are any new severe adverse events observed with this recently approved dosing regimen. The study will also evaluate the rates of eradication of the HCV virus.
This study was terminated due to low enrollment. At the time of termination, 3 participants had enrolled. Therefore, these 3 participants transferred into study P04538 (NCT00727077) and will be included in the P04538 (NCT00727077) data reporting.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IntronA/Rebetol | – | Biological: IntronA (interferon alfa-2b; SCH 30500), Drug: Rebetol (ribavirin; SCH 18908)Children age 3 to 17, with chronic hepatitis C, treated in clinical practice at 10 German sites |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children age 3 to 17 years, with chronic hepatitis C, treated in clinical practice at 10 German sites
Key inclusion criteria (9 listed)
- Patients with chronic hepatitis C (serum HCV-RNA-positive)
- Age 3 to 17 years
- Treatment-naïve
- Platelets >= 100,000/mm^3
- Neutrophil counts >= 1,500/ mm^3
Key exclusion criteria (14 listed)
- Contraindications according to the SPC and European approval
- 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 |
|---|---|---|
| IntronA (interferon alfa-2b; SCH 30500)Also: SCH 30500IntronA (3 Mio I.E./m2, 3 times per week) administered in accordance with the SPC and approved European labeling | Biological | IntronA/Rebetol |
| Rebetol (ribavirin; SCH 18908)Also: SCH 18908Rebetol (15 mg/kg/day) administered in accordance with the SPC and approved European labeling | Drug | IntronA/Rebetol |
Primary outcome
Incidence of serious adverse events
Time frame: After the inclusion of the subject in the study (defined as the time when the subject signs the informed consent) and up to 30 days after the subject completed or discontinued the study
1 secondary outcome
Sustained virologic response (defined as undetectable viral load at 24 weeks post-treatment)
Time frame: Assessed at the end of treatment and 24 weeks post-treatment
Results and safety
The study was stopped early (reason given: Study halted due to low recruitment. The 3 participants at time of termination transferred into study P04538 (NCT00727077). See NCT00727077 for details/results.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2015.
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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 Hepatitis C, Chronic 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 9 inclusion and 14 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 8 Apr 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?
The study was stopped early (reason given: Study halted due to low recruitment. The 3 participants at time of termination transferred into study P04538 (NCT00727077). See NCT00727077 for details/results.). Results are not available in the source record.
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?
Incidence of serious adverse events (time frame: After the inclusion of the subject in the study (defined as the time when the subject signs the informed consent) and up to 30 days after the subject completed or discontinued the study). 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 8 Apr 2015.