Autoimmune HepatitisPhase 4NCT00687180
Mycophenolate vs Azathioprin in Autoimmune Hepatitis
A Phase 4 study testing Treatment with mycophenolat mofetil and Treatment with azathioprin in people with Autoimmune Hepatitis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
A study with 20 de novo patients with autoimmune hepatitis, 10 receiving azathioprin and 10 receiving mycophenolat mofetil. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autoimmune Hepatitis
- What is being tested?
- Treatment with mycophenolat mofetil and Treatment with azathioprin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteDenmark
- Study dates
- Start not givento not given
- 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
- De novo autoimmune hepatitis
- Consent
Who cannot join
- age below 18
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
A study with 20 de novo patients with autoimmune hepatitis, 10 receiving azathioprin and 10 receiving mycophenolat mofetil.
- Conditions
- Autoimmune Hepatitis
- Being tested
- Treatment with mycophenolat mofetil, Treatment with azathioprin
- Keywords
- Prednisolone dosage
- Medical subject headings
- Hepatitis, Autoimmune
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with mycophenolat mofetilDrug
Treatment with azathioprinDrug
| Study group | Role | What they receive |
|---|---|---|
| I | Active comparator | MMF Receives: Drug: Treatment with mycophenolat mofetil |
| II | Active comparator | Not described Receives: Drug: Treatment with azathioprin |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune HepatitisStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00687180
- Sponsor's protocol ID
- MMF vs Imurel
- Status last verified
- May 2008
- First submitted
- 28 May 2008
- Last updated
- 30 May 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mycophenolate vs Azathioprin in Autoimmune Hepatitis
- ClinicalTrials.gov ID
- NCT00687180
- Acronym / sponsor ID
- MMF vs Imurel
- Conditions
- Autoimmune Hepatitis
- Keywords
- Prednisolone dosage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- First posted
- 30 May 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.
A study with 20 de novo patients with autoimmune hepatitis, 10 receiving azathioprin and 10 receiving mycophenolat mofetil.
Study design
- Primary purpose
- Treatment
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | Active comparator | Drug: Treatment with mycophenolat mofetilMMF |
| II | Active comparator | Drug: Treatment with azathioprin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- De novo autoimmune hepatitis
- Consent
Key exclusion criteria (2 listed)
- age below 18
- pregnancy
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 |
|---|---|---|
| Treatment with mycophenolat mofetil | Drug | I |
| Treatment with azathioprin | Drug | II |
Primary outcome
Not reported in the source record.
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 30 May 2008.
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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.
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 Treatment with mycophenolat mofetil and Treatment with azathioprin in people with Autoimmune Hepatitis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 2 inclusion and 2 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 30 May 2008. 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 Denmark. 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.
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 30 May 2008.