Trial · NCT06650124
Induction of Remission in Autoimmune Hepatitis With Azathioprine vs. MMF
NCT06650124, Phase 2, Phase 3, Unknown, Institute of Liver and Biliary Sciences, India
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Induction of Remission in Autoimmune Hepatitis With Azathioprine vs. MMF. Trials, record NCT06650124. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06650124
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Induction of Remission in Autoimmune Hepatitis With Azathioprine vs. MMF
- NCT number
- NCT06650124
- Status
- Unknown
- Phases
- Phase 2, Phase 3
- Enrollment
- 108 participants, estimated
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Conditions
- Autoimmune Hepatitis
- Interventions
- Mycophenolate Mofetil + Prednisolone Participants will receive mycophenolate mofetil in combination., Azathioprine + Prednisolone
- First posted
- 2024-10-21
- Last updated
- 2024-11-07
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Biochemical Remission at 24 Weeks | 24 weeks | Definition: Normalization of liver enzymes (ALT, AST) and immunoglobulin G (IgG) levels. Time Frame: Measured at 24 weeks of treatment. Purpose: To evaluate the effectiveness of mycophenolate mofetil (MMF) versus azathioprine (AZA) in achieving biochemical remission in treatment-naive autoimmune hepatitis (AIH) patients. |
| Secondary | Incidence and Severity of Adverse Events | 24 weeks. | Definition: Number and severity (mild, moderate, or severe) of adverse events related to the treatment. Time Frame: Assessed at each follow-up visit (every 4 weeks) during the 24-week treatment period. Purpose: To compare the safety profiles of MMF and AZA. |
| Secondary | Treatment Adherence | 24 weeks. | Definition: Percentage of participants who complete the 24-week treatment without discontinuation due to adverse events or non-compliance. Time Frame: Measured throughout the 24-week period. Purpose: To assess patient adherence to treatment protocols in both groups. |
| Secondary | Quality of Life Improvement | 24 weeks. | Definition: Change in the quality of life score based on a validated patient-reported outcome questionnaire, SF-36, and CLDQ. Time Frame: Measured at baseline and 24 weeks. Purpose: To determine whether improvements in liver function correlate with better quality of life |
| Secondary | Change in Liver Fibrosis | 24 weeks. | Definition: Change in liver fibrosis stage, measured by Fibroscan. Time Frame: Measured at baseline and 24 weeks. Purpose: To evaluate if either treatment leads to a reduction in liver fibrosis or prevents its progression. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers9
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06650124
GET https://conductscience.org/api/trials/v1/NCT06650124/registered