Trial · NCT01707472
Study of Simtuzumab in HIV and/or Hepatitis C- Infected Adults With Liver Fibrosis
NCT01707472, Phase 2, Completed, Gilead Sciences; results first posted 2019-10-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Simtuzumab in HIV and/or Hepatitis C- Infected Adults With Liver Fibrosis. Trials, record NCT01707472. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01707472
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Simtuzumab in HIV and/or Hepatitis C- Infected Adults With Liver Fibrosis
- NCT number
- NCT01707472
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 18 participants, actual
- Lead sponsor
- Gilead Sciences
- Conditions
- Liver Fibrosis, Hepatitis C, HIV, HIV/HCV Co-infection
- Interventions
- Simtuzumab
- First posted
- 2012-10-16
- Last updated
- 2019-11-05
- Results first posted
- 2019-10-09
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Experiencing Treatment-Emergent Adverse Events | First dose date up to Week 24 plus 30 days | |
| Secondary | Number of Participants With a Change From Baseline in Ishak Fibrosis Stage Score at Week 24 | Baseline; Week 24 | The Ishak fibrosis score measures the degree of liver fibrosis (scarring) and ranges from 0 (best) to 6 (worst). A negative value in change from baseline indicates an improvement and a positive value indicates worsening. |
| Secondary | Change From Baseline in HVPG at Week 24 | Baseline; Week 24 | |
| Secondary | Change From Baseline in MQC at Week 24 | Baseline; Week 24 | |
| Secondary | Change From Baseline in Alpha SMA at Week 24 | Baseline; Week 24 | |
| Secondary | Change From Baseline in Liver Fibrosis as Estimated by MRE at Week 24 | Baseline; Week 24 |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Experiencing Treatment-Emergent Adverse Events | First dose date up to Week 24 plus 30 days | The Safety Analysis Set included participants who received at least one dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With a Change From Baseline in Ishak Fibrosis Stage Score at Week 24 | Baseline; Week 24 | Participants in the Full Analysis Set (who were enrolled into the study and received at least 1 dose of study drug) with available data were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in HVPG at Week 24 | Baseline; Week 24 | Participants in the Full Analysis Set were analyzed. | mm Hg | MEAN |
| SECONDARY | Change From Baseline in MQC at Week 24 | Baseline; Week 24 | Participants in the Full Analysis Set with liver biopsy area ≥ 4 mm\^2 (adequate for morphometry measurements) were analyzed. | percentage of MQC | MEAN |
| SECONDARY | Change From Baseline in Alpha SMA at Week 24 | Baseline; Week 24 | Participants in the Full Analysis Set with liver biopsy area ≥ 4 mm\^2 (adequate for morphometry measurements) were analyzed. | percentage of alpha-SMA | MEAN |
| SECONDARY | Change From Baseline in Liver Fibrosis as Estimated by MRE at Week 24 | Baseline; Week 24 | Participants in the Full Analysis Set with available data were analyzed. | kPa | MEAN |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Experiencing Treatment-Emergent Adverse Events | Simtuzumab in HIV Participants | 100 | percentage of participants | ||
| Percentage of Participants Experiencing Treatment-Emergent Adverse Events | Simtuzumab in HCV Participants | 100 | percentage of participants | ||
| Percentage of Participants Experiencing Treatment-Emergent Adverse Events | Simtuzumab in HIV/HCV Co-Infected Participants | 100 | percentage of participants | ||
| Number of Participants With a Change From Baseline in Ishak Fibrosis Stage Score at Week 24 | Simtuzumab in HIV Participants | Fibrosis improved: -2 | 0 | Participants | |
| Number of Participants With a Change From Baseline in Ishak Fibrosis Stage Score at Week 24 | Simtuzumab in HCV Participants | Fibrosis improved: -2 | 1 | Participants | |
| Number of Participants With a Change From Baseline in Ishak Fibrosis Stage Score at Week 24 | Simtuzumab in HIV/HCV Co-Infected Participants | Fibrosis improved: -2 | 0 | Participants | |
| Number of Participants With a Change From Baseline in Ishak Fibrosis Stage Score at Week 24 | Simtuzumab in HIV Participants | Fibrosis improved: -1 | 1 | Participants | |
| Number of Participants With a Change From Baseline in Ishak Fibrosis Stage Score at Week 24 | Simtuzumab in HCV Participants | Fibrosis improved: -1 | 1 | Participants | |
| Number of Participants With a Change From Baseline in Ishak Fibrosis Stage Score at Week 24 | Simtuzumab in HIV/HCV Co-Infected Participants | Fibrosis improved: -1 | 0 | Participants | |
| Number of Participants With a Change From Baseline in Ishak Fibrosis Stage Score at Week 24 | Simtuzumab in HIV Participants | Fibrosis did not change: 0 | 2 | Participants |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Simtuzumab in HIV Participants | 4 | |
| Overall Study | STARTED | Simtuzumab in HCV Participants | 6 | |
| Overall Study | STARTED | Simtuzumab in HIV/HCV Co-Infected Participants | 8 | |
| Overall Study | COMPLETED | Simtuzumab in HIV Participants | 4 | |
| Overall Study | COMPLETED | Simtuzumab in HCV Participants | 6 | |
| Overall Study | COMPLETED | Simtuzumab in HIV/HCV Co-Infected Participants | 8 | |
| Overall Study | NOT COMPLETED | Simtuzumab in HIV Participants | 0 | |
| Overall Study | NOT COMPLETED | Simtuzumab in HCV Participants | 0 | |
| Overall Study | NOT COMPLETED | Simtuzumab in HIV/HCV Co-Infected Participants | 0 |
Source ClinicalTrials.gov
Adverse events234
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Lymphocytosis | Blood and lymphatic system disorders | Simtuzumab in HIV Participants | 0 | 4 | |
| other | Lymphocytosis | Blood and lymphatic system disorders | Simtuzumab in HCV Participants | 1 | 6 | |
| other | Lymphocytosis | Blood and lymphatic system disorders | Simtuzumab in HIV/HCV Co-Infected Participants | 0 | 8 | |
| other | Abdominal tenderness | Gastrointestinal disorders | Simtuzumab in HIV Participants | 1 | 4 | |
| other | Abdominal tenderness | Gastrointestinal disorders | Simtuzumab in HCV Participants | 0 | 6 | |
| other | Abdominal tenderness | Gastrointestinal disorders | Simtuzumab in HIV/HCV Co-Infected Participants | 0 | 8 | |
| other | Aphthous stomatitis | Gastrointestinal disorders | Simtuzumab in HIV Participants | 0 | 4 | |
| other | Aphthous stomatitis | Gastrointestinal disorders | Simtuzumab in HCV Participants | 1 | 6 | |
| other | Aphthous stomatitis | Gastrointestinal disorders | Simtuzumab in HIV/HCV Co-Infected Participants | 0 | 8 | |
| other | Diarrhoea | Gastrointestinal disorders | Simtuzumab in HIV Participants | 1 | 4 |
1 to 10 of 234Source ClinicalTrials.gov
See all 234 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Simtuzumab in HIV Participants | 0 | 4 |
| Total, all-cause mortality | Simtuzumab in HCV Participants | 0 | 6 |
| Total, all-cause mortality | Simtuzumab in HIV/HCV Co-Infected Participants | 0 | 8 |
| Total, other adverse events | Simtuzumab in HIV Participants | 4 | 4 |
| Total, other adverse events | Simtuzumab in HCV Participants | 6 | 6 |
| Total, other adverse events | Simtuzumab in HIV/HCV Co-Infected Participants | 8 | 8 |
| Total, serious adverse events | Simtuzumab in HIV Participants | 0 | 4 |
| Total, serious adverse events | Simtuzumab in HCV Participants | 0 | 6 |
| Total, serious adverse events | Simtuzumab in HIV/HCV Co-Infected Participants | 1 | 8 |
Source ClinicalTrials.gov
Papers2
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/NCT01707472
GET https://conductscience.org/api/trials/v1/NCT01707472/results?page=2