Trial · NCT01672879

Simtuzumab (SIM, GS-6624) in the Treatment of Cirrhosis Due to NASH

NCT01672879, Phase 2, Terminated, Gilead Sciences; results first posted 2019-03-27

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Simtuzumab (SIM, GS-6624) in the Treatment of Cirrhosis Due to NASH. Trials, record NCT01672879. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01672879

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Simtuzumab (SIM, GS-6624) in the Treatment of Cirrhosis Due to NASH
NCT number: NCT01672879
Status: Terminated
Phases: Phase 2
Enrollment: 259 participants, actual
Lead sponsor: Gilead Sciences
Conditions: Liver Fibrosis Due to NASH
Interventions: Placebo, SIM
First posted: 2012-08-27
Last updated: 2019-03-27
Other registries' IDs: eudract:2012-002489-11
Results first posted: 2019-03-27

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Hepatic Venous Pressure Gradient (HVPG)	Baseline to Week 96
Primary	Event-Free Survival (EFS) Using Kaplan-Meier	Baseline up to the time of clinical event or last dose date (maximum: 240 weeks in Blinded Phase); which ever occurred first	Event free survival (EFS) was the primary clinical efficacy endpoint and was assessed by time to first liver-related event or death, whichever occurs first. Liver-related events included any of the following: * Liver transplantation * Qualification for liver transplantation * Model for End-Stage Liver Disease (MELD) ≥ 15 * Events indicative of hepatic decompensation * Esophageal variceal bleeding * Ascites * Hepatic Encephalopathy * ≥ 2 point increase in Child Pugh-Turcotte (CPT) score * Newly diagnosed varices in a subject without prior varices

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Hepatic Venous Pressure Gradient (HVPG)	Baseline to Week 96	Participants in the Full Analysis Set with available data were analyzed.	mmHg	MEAN
PRIMARY	Event-Free Survival (EFS) Using Kaplan-Meier	Baseline up to the time of clinical event or last dose date (maximum: 240 weeks in Blinded Phase); which ever occurred first	Participants in the Full Analysis Set were analyzed.	months	MEDIAN

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in Hepatic Venous Pressure Gradient (HVPG)	SIM 200 mg	-0.1	Standard Deviation 3.76	mmHg
Change From Baseline in Hepatic Venous Pressure Gradient (HVPG)	SIM 700 mg	0.0	Standard Deviation 4.23	mmHg
Change From Baseline in Hepatic Venous Pressure Gradient (HVPG)	Placebo	-0.1	Standard Deviation 4.01	mmHg
Event-Free Survival (EFS) Using Kaplan-Meier	SIM 200 mg	NA	95% Confidence Interval NA to NA	months
Event-Free Survival (EFS) Using Kaplan-Meier	SIM 700 mg	NA	95% Confidence Interval NA to NA	months
Event-Free Survival (EFS) Using Kaplan-Meier	Placebo	NA	95% Confidence Interval NA to NA	months

Source ClinicalTrials.gov

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Blinded Phase (Up to 240 Weeks)	STARTED	SIM 200 mg	87
Blinded Phase (Up to 240 Weeks)	STARTED	SIM 700 mg	86
Blinded Phase (Up to 240 Weeks)	STARTED	Placebo	86
Blinded Phase (Up to 240 Weeks)	COMPLETED	SIM 200 mg	0
Blinded Phase (Up to 240 Weeks)	COMPLETED	SIM 700 mg	0
Blinded Phase (Up to 240 Weeks)	COMPLETED	Placebo	0
Blinded Phase (Up to 240 Weeks)	NOT COMPLETED	SIM 200 mg	87
Blinded Phase (Up to 240 Weeks)	NOT COMPLETED	SIM 700 mg	86
Blinded Phase (Up to 240 Weeks)	NOT COMPLETED	Placebo	86
Open-Label Phase (Up to 240 Weeks)	STARTED	SIM 200 mg	15

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events980

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
other	Anaemia	Blood and lymphatic system disorders	Blinded Phase: SIM 200 mg	10	87
other	Anaemia	Blood and lymphatic system disorders	Blinded Phase: SIM 700 mg	7	86
other	Anaemia	Blood and lymphatic system disorders	Blinded Phase: Placebo	6	85
other	Anaemia	Blood and lymphatic system disorders	Open-Label Phase: SIM 700 mg	3	40
other	Splenomegaly	Blood and lymphatic system disorders	Blinded Phase: SIM 200 mg	3	87
other	Splenomegaly	Blood and lymphatic system disorders	Blinded Phase: SIM 700 mg	4	86
other	Splenomegaly	Blood and lymphatic system disorders	Blinded Phase: Placebo	6	85
other	Splenomegaly	Blood and lymphatic system disorders	Open-Label Phase: SIM 700 mg	0	40
other	Palpitations	Cardiac disorders	Blinded Phase: SIM 200 mg	6	87
other	Palpitations	Cardiac disorders	Blinded Phase: SIM 700 mg	1	86

1 to 10 of 980Source ClinicalTrials.gov

See all 980 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Blinded Phase: SIM 200 mg
Total, all-cause mortality	Blinded Phase: SIM 700 mg
Total, all-cause mortality	Blinded Phase: Placebo
Total, all-cause mortality	Open-Label Phase: SIM 700 mg
Total, other adverse events	Blinded Phase: SIM 200 mg	85	87
Total, other adverse events	Blinded Phase: SIM 700 mg	81	86
Total, other adverse events	Blinded Phase: Placebo	83	85
Total, other adverse events	Open-Label Phase: SIM 700 mg	32	40
Total, serious adverse events	Blinded Phase: SIM 200 mg	37	87
Total, serious adverse events	Blinded Phase: SIM 700 mg	36	86

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
29990488	DERIVED	PubMed
33307033	DERIVED	PubMed
36750244	DERIVED	PubMed

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01672879

GET https://conductscience.org/api/trials/v1/NCT01672879/events?page=2

API reference For AI assistants