Trial · NCT01672853

Simtuzumab (GS-6624) in the Prevention of Progression of Liver Fibrosis in Adults With Primary Sclerosing Cholangitis (PSC)

NCT01672853, Phase 2, Completed, Gilead Sciences; results first posted 2019-10-22

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Simtuzumab (GS-6624) in the Prevention of Progression of Liver Fibrosis in Adults With Primary Sclerosing Cholangitis (PSC). Trials, record NCT01672853. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01672853

On this page

Trial

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

Title: Simtuzumab (GS-6624) in the Prevention of Progression of Liver Fibrosis in Adults With Primary Sclerosing Cholangitis (PSC)
NCT number: NCT01672853
Status: Completed
Phases: Phase 2
Enrollment: 235 participants, actual
Lead sponsor: Gilead Sciences
Conditions: Primary Sclerosing Cholangitis (PSC)
Interventions: Simtuzumab, Placebo
First posted: 2012-08-27
Last updated: 2019-10-22
Other registries' IDs: eudract:2012-002473-61
Results first posted: 2019-10-22

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Change From Baseline in MQC on Liver Biopsy at Week 96	Baseline; Week 96
Secondary	Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event	First dose date up to Week 96
Secondary	Study Drug Exposure	First dose date up to Week 96	The average SIM exposure was summarized.
Secondary	Percentage of Participants Experiencing Any Treatment-Emergent Laboratory Abnormality	First dose date up to Week 96 plus 30 days	A treatment-emergent graded laboratory abnormality was defined as an increase of at least 1 abnormality grade from the predose assessment and occurring after the predose visit and on or before the date of the administration of study drug plus 30 days. The most severe graded abnormality from all tests was counted for each participant \[Grade 1 (mild); Grade 2 (moderate); Grade 3 (severe); Grade 4 (life-threatening)\].

Source ClinicalTrials.gov

Outcomes4

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 MQC on Liver Biopsy at Week 96	Baseline; Week 96	Participants in the Full Analysis Set (participants who were randomized into the study and received at least 1 dose of study drug) with available data were analyzed.	percentage of MQC	MEAN
SECONDARY	Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event	First dose date up to Week 96	The Safety Analysis Set included participants who received at least 1 dose of study drug.	percentage of participants	NUMBER
SECONDARY	Study Drug Exposure	First dose date up to Week 96	Participants in the Safety Analysis Set were analyzed.	weeks	MEAN
SECONDARY	Percentage of Participants Experiencing Any Treatment-Emergent Laboratory Abnormality	First dose date up to Week 96 plus 30 days	Participants in the Safety Analysis Set with at least one post-baseline measurement were analyzed.	percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group21

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

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in MQC on Liver Biopsy at Week 96	SIM 75 mg		-0.5	Standard Deviation 5.78	percentage of MQC
Change From Baseline in MQC on Liver Biopsy at Week 96	SIM 125 mg		0.5	Standard Deviation 6.94	percentage of MQC
Change From Baseline in MQC on Liver Biopsy at Week 96	Placebo		0.0	Standard Deviation 4.76	percentage of MQC
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event	SIM 75 mg		5.1		percentage of participants
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event	SIM 125 mg		7.8		percentage of participants
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event	Placebo		10.3		percentage of participants
Study Drug Exposure	SIM 75 mg		92.0	Standard Deviation 15.33	weeks
Study Drug Exposure	SIM 125 mg		83.8	Standard Deviation 26.12	weeks
Study Drug Exposure	Placebo		87.4	Standard Deviation 22.35	weeks
Percentage of Participants Experiencing Any Treatment-Emergent Laboratory Abnormality	SIM 75 mg	Grade 1	11.4		percentage of participants

1 to 10 of 21Source ClinicalTrials.gov

See all 21 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	SIM 75 mg	79
Overall Study	STARTED	SIM 125 mg	77
Overall Study	STARTED	Placebo	79
Overall Study	COMPLETED	SIM 75 mg	69
Overall Study	COMPLETED	SIM 125 mg	60
Overall Study	COMPLETED	Placebo	65
Overall Study	NOT COMPLETED	SIM 75 mg	10
Overall Study	NOT COMPLETED	SIM 125 mg	17
Overall Study	NOT COMPLETED	Placebo	14

Source ClinicalTrials.gov

Adverse events366

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	SIM 75 mg	4	79
other	Anaemia	Blood and lymphatic system disorders	SIM 125 mg	3	77
other	Anaemia	Blood and lymphatic system disorders	Placebo	4	78
other	Abdominal discomfort	Gastrointestinal disorders	SIM 75 mg	4	79
other	Abdominal discomfort	Gastrointestinal disorders	SIM 125 mg	4	77
other	Abdominal discomfort	Gastrointestinal disorders	Placebo	3	78
other	Abdominal distension	Gastrointestinal disorders	SIM 75 mg	4	79
other	Abdominal distension	Gastrointestinal disorders	SIM 125 mg	3	77
other	Abdominal distension	Gastrointestinal disorders	Placebo	6	78
other	Abdominal pain	Gastrointestinal disorders	SIM 75 mg	13	79

1 to 10 of 366Source ClinicalTrials.gov

See all 366 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	SIM 75 mg	0	79
Total, all-cause mortality	SIM 125 mg	0	77
Total, all-cause mortality	Placebo	0	78
Total, other adverse events	SIM 75 mg	71	79
Total, other adverse events	SIM 125 mg	72	77
Total, other adverse events	Placebo	75	78
Total, serious adverse events	SIM 75 mg	16	79
Total, serious adverse events	SIM 125 mg	23	77
Total, serious adverse events	Placebo	21	78

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
30153359	DERIVED	PubMed
38967589	DERIVED	PubMed
39996122	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/NCT01672853

GET https://conductscience.org/api/trials/v1/NCT01672853/results?page=2

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