Hepatitis CPhase 4RibadosNCT00484328
Ribavirin, Its Dosing Regime
A Phase 4 study testing Ribavirin in people with Hepatitis C, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The purpose of this study is to determine if the medicines for chronic hepatitis C can be taken once daily, instead of twice daily. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Ribavirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2007to Dec 2012
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- anti-HCV positivity > 6 months
- Positive HCV-RNA genotype 1 or 4
- Liver biopsy within one year before the start of therapy
- Intention to be treated and participate treatment
- body weight at or above 75 kg
Who cannot join
- HIV positive
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine if the medicines for chronic hepatitis C can be taken once daily, instead of twice daily.
Read the detailed description
The standard treatment of patients with chronic hepatitis C infection (HCV) is treatment with ribavirin. Actually, the compliance (2x daily) seems to be a problem. To increase patients' compliance, it is investigated if the total dose of ribavirin can be taken once daily.
The pharmacokinetics of ribavirin at different dosage regimes is investigated.
- Conditions
- Hepatitis C
- Being tested
- Ribavirin
- Keywords
- hepatitis C, Ribavirin, Dosage, Pharmacokinetics
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RibavirinDrug
different dosing regimes of Ribavirin
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Ribavirin |
| 2 | Experimental | Not described Receives: Drug: Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The pharmacokinetics of ribavirin at different dosage regimes, measured by the area under the curve of the concentration-time graph
Measured: within 24 weeks after enrollment
Secondary outcomes (4)
The tolerability of the treatment at different dosage regimes of ribavirin
Measured: 24 weeks of treatment
The antioxidant capacity in plasma and erythrocytes at different dosing regimes
Measured: 24 weeks of treatment
The effect of ribavirin on the hemolysis
Measured: 24 weeks of treatment
The pharmacokinetics of ribavirin in erythrocytes in the different dosing regimes
Measured: 24 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2007 (estimated)
- Study startJul 2007
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Investigators
- Aalt Bast, Prof.Dr., Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00484328
- Sponsor's protocol ID
- MEC-07-3-007
- Acronym
- Ribados
- Status last verified
- Jul 2011
- First submitted
- 7 Jun 2007
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ribavirin, Its Dosing Regime
- ClinicalTrials.gov ID
- NCT00484328
- Acronym / sponsor ID
- Ribados / MEC-07-3-007
- Conditions
- Hepatitis C
- Keywords
- hepatitis C, Ribavirin, Dosage, Pharmacokinetics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- Jul 2007
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 8 Jun 2007 (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 purpose of this study is to determine if the medicines for chronic hepatitis C can be taken once daily, instead of twice daily.
Detailed description
The standard treatment of patients with chronic hepatitis C infection (HCV) is treatment with ribavirin. Actually, the compliance (2x daily) seems to be a problem. To increase patients' compliance, it is investigated if the total dose of ribavirin can be taken once daily.
The pharmacokinetics of ribavirin at different dosage regimes is investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Ribavirin |
| 2 | Experimental | Drug: Ribavirin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- anti-HCV positivity > 6 months
- Positive HCV-RNA genotype 1 or 4
- Liver biopsy within one year before the start of therapy
- Intention to be treated and participate treatment
- body weight at or above 75 kg
Key exclusion criteria (1 listed)
- HIV positive
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 |
|---|---|---|
| Ribavirindifferent dosing regimes of Ribavirin | Drug | 1, 2 |
Primary outcome
The pharmacokinetics of ribavirin at different dosage regimes, measured by the area under the curve of the concentration-time graph
Time frame: within 24 weeks after enrollment
4 secondary outcomes
The tolerability of the treatment at different dosage regimes of ribavirin
Time frame: 24 weeks of treatment
The antioxidant capacity in plasma and erythrocytes at different dosing regimes
Time frame: 24 weeks of treatment
The effect of ribavirin on the hemolysis
Time frame: 24 weeks of treatment
The pharmacokinetics of ribavirin in erythrocytes in the different dosing regimes
Time frame: 24 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2018.
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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.
Aalt Bast, Prof.Dr. principal investigator
Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ribavirin in people with Hepatitis C, run by Maastricht University Medical Center at 1 site in Netherlands.
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 5 inclusion and 1 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 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The pharmacokinetics of ribavirin at different dosage regimes, measured by the area under the curve of the concentration-time graph (time frame: within 24 weeks after enrollment). 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 9 Jan 2018.