Trial · NCT04790916
Effect of RO7049665 on the Time to Relapse Following Steroid Tapering in Participants With Autoimmune Hepatitis (AIH)
NCT04790916, Phase 2, Terminated, Hoffmann-La Roche; results first posted 2023-09-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of RO7049665 on the Time to Relapse Following Steroid Tapering in Participants With Autoimmune Hepatitis (AIH). Trials, record NCT04790916. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04790916
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of RO7049665 on the Time to Relapse Following Steroid Tapering in Participants With Autoimmune Hepatitis (AIH)
- NCT number
- NCT04790916
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 2 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Autoimmune Hepatitis, Autoimmune Chronic Hepatitis
- Interventions
- RO7049665, Placebo
- First posted
- 2021-03-10
- Last updated
- 2023-09-18
- Other registries' IDs
- eudract:2020-003990-23
- Results first posted
- 2023-09-18
- Limitations and caveats
The study was terminated by the Sponsor. Only 2 participants were enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Relapse for RO7049665 7.5 mg Versus Placebo | From randomization (Day 1) up to relapse or end of the study (up to approximately 25 months) | The study was terminated by the Sponsor. Only 2 participants were enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality. |
| Secondary | Change From Baseline in Alanine Aminotransferase (ALT) | Up to end of the study (up to approximately 25 months) | The study was terminated by the Sponsor. Only 2 participants were enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality. |
| Secondary | Change From Baseline in Aspartate Aminotransferase (AST) | Up to end of the study (up to approximately 25 months) | The study was terminated by the Sponsor. Only 2 participants were enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality. |
| Secondary | Change From Baseline in Immunoglobulin G (IgG) | Up to end of the study (up to approximately 25 months) | The study was terminated by the Sponsor. Only 2 participants were enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality. |
| Secondary | Time to Relapse for RO7049665 3.5 mg Versus Placebo | From Randomization (Day 1) up to relapse or end of the study (up to approximately 25 months) | The study was terminated by the Sponsor. Only 2 participants were enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality. |
| Secondary | Percentage of Participants With Adverse Events (AEs) | Up to end of the study (up to approximately 25 months) | The study was terminated by the Sponsor. Only 2 participants were enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality. |
| Secondary | Number of Participants With Anti-drug Antibody (ADA) Emergence and Neutralizing Potential | Up to end of the study (up to approximately 25 months) | The study was terminated by the Sponsor. Only 2 participants were enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Relapse for RO7049665 7.5 mg Versus Placebo | From randomization (Day 1) up to relapse or end of the study (up to approximately 25 months) | The study was terminated by the Sponsor. Only 2 participants were enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality. | ||
| SECONDARY | Change From Baseline in Alanine Aminotransferase (ALT) | Up to end of the study (up to approximately 25 months) | The study was terminated by the Sponsor. Only 2 participants were enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality. | ||
| SECONDARY | Change From Baseline in Aspartate Aminotransferase (AST) | Up to end of the study (up to approximately 25 months) | The study was terminated by the Sponsor. Only 2 participants were enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality. | ||
| SECONDARY | Change From Baseline in Immunoglobulin G (IgG) | Up to end of the study (up to approximately 25 months) | The study was terminated by the Sponsor. Only 2 participants were enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality. | ||
| SECONDARY | Time to Relapse for RO7049665 3.5 mg Versus Placebo | From Randomization (Day 1) up to relapse or end of the study (up to approximately 25 months) | The study was terminated by the Sponsor. Only 2 participants were enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality. | ||
| SECONDARY | Percentage of Participants With Adverse Events (AEs) | Up to end of the study (up to approximately 25 months) | The study was terminated by the Sponsor. Only 2 participants were enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality. | ||
| SECONDARY | Number of Participants With Anti-drug Antibody (ADA) Emergence and Neutralizing Potential | Up to end of the study (up to approximately 25 months) | The study was terminated by the Sponsor. Only 2 participants were enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | RO7049665 3.5 mg | 0 | |
| Overall Study | STARTED | RO7049665 7.5 mg | 0 | |
| Overall Study | STARTED | Placebo | 0 | |
| Overall Study | COMPLETED | RO7049665 3.5 mg | 0 | |
| Overall Study | COMPLETED | RO7049665 7.5 mg | 0 | |
| Overall Study | COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | RO7049665 3.5 mg | 0 | |
| Overall Study | NOT COMPLETED | RO7049665 7.5 mg | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
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 totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | RO7049665 3.5 mg | 0 | 0 |
| Total, all-cause mortality | RO7049665 7.5 mg | 0 | 0 |
| Total, all-cause mortality | Placebo | 0 | 0 |
| Total, other adverse events | RO7049665 3.5 mg | 0 | 0 |
| Total, other adverse events | RO7049665 7.5 mg | 0 | 0 |
| Total, other adverse events | Placebo | 0 | 0 |
| Total, serious adverse events | RO7049665 3.5 mg | 0 | 0 |
| Total, serious adverse events | RO7049665 7.5 mg | 0 | 0 |
| Total, serious adverse events | Placebo | 0 | 0 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT04790916
GET https://conductscience.org/api/trials/v1/NCT04790916/registered