Trial · NCT01759511

Long-Term Safety Study of GS-6624 in Adults With Idiopathic Pulmonary Fibrosis (IPF)

NCT01759511, Phase 2, Terminated, Gilead Sciences; results first posted 2017-04-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Long-Term Safety Study of GS-6624 in Adults With Idiopathic Pulmonary Fibrosis (IPF). Trials, record NCT01759511. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01759511

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Trial

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

Title: Long-Term Safety Study of GS-6624 in Adults With Idiopathic Pulmonary Fibrosis (IPF)
NCT number: NCT01759511
Status: Terminated
Phases: Phase 2
Enrollment: 34 participants, actual
Lead sponsor: Gilead Sciences
Conditions: Idiopathic Pulmonary Fibrosis
Interventions: Simtuzumab
First posted: 2013-01-03
Last updated: 2017-04-04
Results first posted: 2017-04-04

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Overall Safety Profile of Simtuzumab	30 days post last study treatment (up to 165 weeks)	The overall safety of simtuzumab was assessed as the percentage of participants experiencing adverse events (AEs; Serious AEs, Grade 3 or 4 AEs, AEs related to simtuzumab, and AEs leading to discontinuation of simtuzumab), treatment-emergent chemistry and hematology abnormality.
Secondary	Relative Change From Baseline in FVC % Predicted at Weeks 72 and 144	Weeks 72 and 144	* FVC was a pulmonary function test, and was defined as the volume of air that can forcibly be blown out after taking a full breath. * Least square means were from mixed model for repeated measures (MMRM) model including baseline FVC % predicted and visit including all data up to Week 144.
Secondary	Relative Change From Baseline in DLCO % Predicted at Weeks 72 and 144	Weeks 72 and 144	* DLCO was a measurement to determine the extent to which oxygen passes from the air sacs of the lungs into the blood. * Least square means were from MMRM model including baseline DLCO % predicted and visit including all data up to Week 144.
Secondary	All-cause Mortality	Up to 165 weeks	All-cause mortality was assessed as a number of participants who died from any cause.
Secondary	Relative Change From Baseline in Serum Lysyl Oxidase-like 2 (sLOXL2) Levels at Weeks 72 and 120	Weeks 72 and 120

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Overall Safety Profile of Simtuzumab	30 days post last study treatment (up to 165 weeks)	Safety Analysis Set	percentage of participants	NUMBER
SECONDARY	Relative Change From Baseline in FVC % Predicted at Weeks 72 and 144	Weeks 72 and 144	Participants in Safety Analysis Set with available data were analyzed.	percent change in FVC % predicted	LEAST_SQUARES_MEAN
SECONDARY	Relative Change From Baseline in DLCO % Predicted at Weeks 72 and 144	Weeks 72 and 144	Participants in Safety Analysis Set with available data were analyzed.	percent change in DLCO % predicted	LEAST_SQUARES_MEAN
SECONDARY	All-cause Mortality	Up to 165 weeks	Safety Analysis Set	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Relative Change From Baseline in Serum Lysyl Oxidase-like 2 (sLOXL2) Levels at Weeks 72 and 120	Weeks 72 and 120	Participants in the Safety Analysis set with available data were analyzed.	percent change in sLOXL2	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group12

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

Outcome	Group	Category	Value	Spread	Units
Overall Safety Profile of Simtuzumab	Simtuzumab	Adverse Events (AEs)	97.1		percentage of participants
Overall Safety Profile of Simtuzumab	Simtuzumab	Grade 3 or 4 AEs	47.1		percentage of participants
Overall Safety Profile of Simtuzumab	Simtuzumab	Serious Adverse Events	35.3		percentage of participants
Overall Safety Profile of Simtuzumab	Simtuzumab	SAEs Related to simtuzumab	5.9		percentage of participants
Overall Safety Profile of Simtuzumab	Simtuzumab	AEs leading to discontinuation of simtuzumab	29.4		percentage of participants
Relative Change From Baseline in FVC % Predicted at Weeks 72 and 144	Simtuzumab	Week 72	-8.05	Standard Error 1.829	percent change in FVC % predicted
Relative Change From Baseline in FVC % Predicted at Weeks 72 and 144	Simtuzumab	Week 144	-12.04	Standard Error 2.086	percent change in FVC % predicted
Relative Change From Baseline in DLCO % Predicted at Weeks 72 and 144	Simtuzumab	Week 72	-7.41	Standard Error 3.062	percent change in DLCO % predicted
Relative Change From Baseline in DLCO % Predicted at Weeks 72 and 144	Simtuzumab	Week 144	-22.80	Standard Error 3.475	percent change in DLCO % predicted
All-cause Mortality	Simtuzumab		3		Participants

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Simtuzumab	34
Overall Study	COMPLETED	Simtuzumab	0
Overall Study	NOT COMPLETED	Simtuzumab	34

Source ClinicalTrials.gov

Adverse events89

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	Simtuzumab	4	34
other	Tachycardia	Cardiac disorders	Simtuzumab	2	34
other	Cataract	Eye disorders	Simtuzumab	2	34
other	Dry eye	Eye disorders	Simtuzumab	2	34
other	Abdominal discomfort	Gastrointestinal disorders	Simtuzumab	2	34
other	Abdominal pain	Gastrointestinal disorders	Simtuzumab	2	34
other	Abdominal pain upper	Gastrointestinal disorders	Simtuzumab	2	34
other	Constipation	Gastrointestinal disorders	Simtuzumab	7	34
other	Diarrhoea	Gastrointestinal disorders	Simtuzumab	5	34
other	Flatulence	Gastrointestinal disorders	Simtuzumab	2	34

1 to 10 of 89Source ClinicalTrials.gov

See all 89 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Simtuzumab	3	34
Total, other adverse events	Simtuzumab	33	34
Total, serious adverse events	Simtuzumab	12	34

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.

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/NCT01759511

GET https://conductscience.org/api/trials/v1/NCT01759511/events?page=2

API reference For AI assistants