Trial · NCT00244751

Antifibrotic Activity Of GI262570 In Chronic Hepatitis C Subjects

NCT00244751, Phase 2, Completed, GlaxoSmithKline; results first posted 2017-12-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Antifibrotic Activity Of GI262570 In Chronic Hepatitis C Subjects. Trials, record NCT00244751. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00244751

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Trial

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

Title: Antifibrotic Activity Of GI262570 In Chronic Hepatitis C Subjects
NCT number: NCT00244751
Status: Completed
Phases: Phase 2
Enrollment: 265 participants, actual
Lead sponsor: GlaxoSmithKline
Conditions: Cirrhosis, Liver
Interventions: GI262570 0.5 mg, GI262570 1.0 mg, Placebo
First posted: 2005-10-27
Last updated: 2017-12-11
Results first posted: 2017-12-11

Source ClinicalTrials.gov

Registered outcomes28

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

List	Outcome	Time frame	Description
Primary	Mean Change From Baseline in Liver Biopsy Immunohistochemical Marker of Hepatic Stellate Cell (HSC) Activation and Collagen Synthesis at Week 52	Baseline and Week 52	A percutaneous liver biopsy was obtained at the screening visit and at Week 52. A new liver biopsy at the screening visit was not taken in the event that a previous liver biopsy taken within 120 days of the Baseline /Day 1 visit (day of first dose), and the tissue block was available. The immunohistochemical marker assessed was smooth muscle alpha-actin (aSMA). Sections of the liver biopsies were stained by standard immunocytochemical techniques using a monoclonal antibody to smooth muscle actin with 'very intense purple' as the detection chromogen. This gives a reddish-purple color to the activated stellate cells, which strongly contrasts with the rest of the tissue. Change from Baseline was calculated as the post Baseline assessment minus the Baseline assessment for a given parameter. If either the Baseline or on-treatment value was missing, the change from Baseline value was also set to missing. The values are presented as proportion of positive area over total area.
Primary	Mean Change From Baseline in Fibrosis as Quantified by Morphometric Image Analysis	Baseline and at Week 52	A percutaneous liver biopsy was obtained at the screening visit and at Week 52. A new liver biopsy at the screening visit was not taken in the event that a previous liver biopsy taken within 120 days of the Baseline /Day 1 visit (day of first dose), and the tissue block was available. Morphometric analysis was performed using specimens stained with Sirius red and computerized image analysis. Sirius red was used to stain extracellular collagen in liver sections. Change from Baseline was calculated as the post Baseline assessment minus the Baseline assessment for a given parameter. If either the Baseline or on-treatment value was missing, the change from Baseline value was also set to missing. The values are presented as proportion of positive area over total area.
Primary	Number of Participants With Ranked Histological Assessment of the Paired Biopsies at Week 52	Week 52	In ranked assessment (fibrosis and necroinflammation), available slides from each participant were evaluated as to whether one slide presents a globally more benign histopathology or whether the matched slides comprise globally equivalent histologic patterns. Subsequent data analysis revealed whether slides scored (within matched pairs of slides) as more benign occurred in different proportions of the Week 52 liver biopsies, according to treatment group. The number of participants with paired biopsies was based on the number with a Rank Assessment.
Primary	Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)	Up to 4 weeks post treatment (52 weeks)	AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.
Primary	Number of Participants With Abnormal ECG Findings	Up to 4 weeks post-treatment (52 weeks)	A standardized 12-lead ECGs were recorded at pre-screening, and pre-dose, at Baseline/Day 1, Weeks 16, 34, and 52 or withdrawal and at the 4 week follow-up visit. Any conditions such as bundle branch block, repolarization, depolarization, abnormal sinus rhythms, atrial fibrillation etc. are considered to be clinically abnormal findings.
Primary	Number of Participants With Change in Toxicities Grades 3 and 4 of Laboratory Parameters Over Time	Up to 4 weeks post-treatment (52 weeks)	Clinical laboratory parameters: Alkaline phosphatase, Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Total bilirubin, Cholesterol, Carbon dioxide content/Bicarbonate (CO2/HCO3), Creatinine, Glucose, Hemoglobin, Potassium, Low density lipid (LDL) cholesterol, Lymphocytes, Sodium, Segmented neutrophils, Platelet count, White blood cell (WBC) count were assessed for change in grade toxicities. Toxicities were graded as grade 1 to grade 4 in increasing order of severity of toxicity. Thus grade 4 indicating severe toxicity. Only those parameters with grade 3 and 4 toxicities are presented.
Primary	Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DSP)	Baseline and up to 4 weeks post-treatment (52 weeks)	SBP and DBP readings were taken at pre-screening, pre-dose after 10 minutes of rest, at Baseline/Day 1, weeks 2, 4, 10, 16, 22, 28, 34, 40, 46, and 52 or WD and at the 4 week follow-up visit. Day 1 (before dosing) value was considered to be as Baseline value. Change from Baseline was calculated as the post Baseline assessment minus the Baseline assessment for a given parameter. If either the Baseline or on-treatment value was missing, the change from Baseline value was also set to missing.
Primary	Mean Change From Baseline in Heart Rate	Baseline and up to 4 weeks post-treatment (52 weeks)	Heart rate assessment were done at pre-screening, pre-dose after 10 minutes of rest, at Baseline/Day 1, weeks 2, 4, 10, 16, 22, 28, 34, 40, 46, and 52 or WD and at the 4 week follow-up visit. Day 1 (before dosing) value was considered to be as Baseline value. Change from Baseline was calculated as the post Baseline assessment minus the Baseline assessment for a given parameter. If either the Baseline or on-treatment value was missing, the change from Baseline value was also set to be missing.
Primary	Number of Participants With Fluid Retention Events	Up to 4 weeks post-treatment (52 weeks)	Fluid retention event was one of the AEs reported. AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Secondary	Number of Participants Progressing at Least 1 Point on the Ishak Fibrosis Score at Week 52	Week 52	Progression was defined as an increase by at least one point in the fibrosis score. Score ranged from 0 to 6 (higher score indicates greater fibrosis). 0: No fibrosis, 1: Fibrous expansion of some portal areas, with or without short fibrous septa, 2: Fibrous expansion of most portal areas, with or without short fibrous septa, 3: Fibrous expansion of most portal areas with portal to portal bridging, 4: Fibrous expansion of portal areas with marked bridging, 5: Marked bridging with occasional nodules (incomplete cirrhosis), 6: Cirrhosis, probable or definite. The number of participants with paired biopsies is based on the number with an Ishak Fibrosis score.

1 to 10 of 28Source ClinicalTrials.gov

See all 28 registered outcomes

Outcomes28

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Mean Change From Baseline in Liver Biopsy Immunohistochemical Marker of Hepatic Stellate Cell (HSC) Activation and Collagen Synthesis at Week 52	Baseline and Week 52	Modified Intent to Treat (MITT) Population consisted of all participants with chronic hepatitis C randomized, regardless of whether or not the study drug was actually taken or if the participant completed the planned duration of the study. Only those participants with data available at the indicated time points were analyzed.	Ratio of positive area	MEAN
PRIMARY	Mean Change From Baseline in Fibrosis as Quantified by Morphometric Image Analysis	Baseline and at Week 52	MITT Population. Only those participants with data available at the indicated time point were analyzed.	Ratio of positive area	MEAN
PRIMARY	Number of Participants With Ranked Histological Assessment of the Paired Biopsies at Week 52	Week 52	MITT Population. Only those participants with paired biopsies at the indicated time point were analyzed.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)	Up to 4 weeks post treatment (52 weeks)	As Treated Population consisted of all participants for whom no clear evidence was available of failure to take study medication.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Abnormal ECG Findings	Up to 4 weeks post-treatment (52 weeks)	As Treated Population. Only those participants available at the specified time points were analyzed.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Change in Toxicities Grades 3 and 4 of Laboratory Parameters Over Time	Up to 4 weeks post-treatment (52 weeks)	As Treated Population. Only those participants available at the specified time points for particular parameter were analyzed.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DSP)	Baseline and up to 4 weeks post-treatment (52 weeks)	As Treated Population. Only those participants available at the specified time points were analyzed.	Millimeter of mercury	MEAN
PRIMARY	Mean Change From Baseline in Heart Rate	Baseline and up to 4 weeks post-treatment (52 weeks)	As treated population. Only those participants available at the specified time points were analyzed.	beats per minute	MEAN
PRIMARY	Number of Participants With Fluid Retention Events	Up to 4 weeks post-treatment (52 weeks)	As Treated Population.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants Progressing at Least 1 Point on the Ishak Fibrosis Score at Week 52	Week 52	MITT Population.	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 28Source ClinicalTrials.gov

See all 28 outcomes

Results by group321

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

Outcome	Group	Category	Value	Spread	Units
Mean Change From Baseline in Liver Biopsy Immunohistochemical Marker of Hepatic Stellate Cell (HSC) Activation and Collagen Synthesis at Week 52	Placebo		0.02065	Standard Deviation 0.047620	Ratio of positive area
Mean Change From Baseline in Liver Biopsy Immunohistochemical Marker of Hepatic Stellate Cell (HSC) Activation and Collagen Synthesis at Week 52	GI262570 0.5mg		0.02819	Standard Deviation 0.048160	Ratio of positive area
Mean Change From Baseline in Liver Biopsy Immunohistochemical Marker of Hepatic Stellate Cell (HSC) Activation and Collagen Synthesis at Week 52	GI262570 1.0mg		0.02914	Standard Deviation 0.040948	Ratio of positive area
Mean Change From Baseline in Fibrosis as Quantified by Morphometric Image Analysis	Placebo		0.02541	Standard Deviation 0.058338	Ratio of positive area
Mean Change From Baseline in Fibrosis as Quantified by Morphometric Image Analysis	GI262570 0.5 mg		0.02613	Standard Deviation 0.055985	Ratio of positive area
Mean Change From Baseline in Fibrosis as Quantified by Morphometric Image Analysis	GI262570 1.0 mg		0.02527	Standard Deviation 0.060665	Ratio of positive area
Number of Participants With Ranked Histological Assessment of the Paired Biopsies at Week 52	Placebo	Fibrosis, better than screening	13		Participants
Number of Participants With Ranked Histological Assessment of the Paired Biopsies at Week 52	GI262570 0.5mg	Fibrosis, better than screening	17		Participants
Number of Participants With Ranked Histological Assessment of the Paired Biopsies at Week 52	GI262570 1.0mg	Fibrosis, better than screening	11		Participants
Number of Participants With Ranked Histological Assessment of the Paired Biopsies at Week 52	Placebo	Fibrosis, same as screening	35		Participants

1 to 10 of 321Source ClinicalTrials.gov

See all 321 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	88
Overall Study	STARTED	GI262570 0.5 mg	89
Overall Study	STARTED	GI262570 1.0 mg	88
Overall Study	COMPLETED	Placebo	72
Overall Study	COMPLETED	GI262570 0.5 mg	74
Overall Study	COMPLETED	GI262570 1.0 mg	78
Overall Study	NOT COMPLETED	Placebo	16
Overall Study	NOT COMPLETED	GI262570 0.5 mg	15
Overall Study	NOT COMPLETED	GI262570 1.0 mg	10

Source ClinicalTrials.gov

Adverse events132

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	Diarrhoea	Gastrointestinal disorders	Placebo	3	88
other	Diarrhoea	Gastrointestinal disorders	GI262570 0.5 mg	10	89
other	Diarrhoea	Gastrointestinal disorders	GI262570 1.0 mg	4	88
other	Nausea	Gastrointestinal disorders	Placebo	7	88
other	Nausea	Gastrointestinal disorders	GI262570 0.5 mg	3	89
other	Nausea	Gastrointestinal disorders	GI262570 1.0 mg	6	88
other	Abdominal pain	Gastrointestinal disorders	Placebo	5	88
other	Abdominal pain	Gastrointestinal disorders	GI262570 0.5 mg	4	89
other	Abdominal pain	Gastrointestinal disorders	GI262570 1.0 mg	4	88
other	Abdominal pain upper	Gastrointestinal disorders	Placebo	6	88

1 to 10 of 132Source ClinicalTrials.gov

See all 132 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	88
Total, all-cause mortality	GI262570 0.5 mg	0	89
Total, all-cause mortality	GI262570 1.0 mg	0	88
Total, other adverse events	Placebo	58	88
Total, other adverse events	GI262570 0.5 mg	50	89
Total, other adverse events	GI262570 1.0 mg	55	88
Total, serious adverse events	Placebo	7	88
Total, serious adverse events	GI262570 0.5 mg	10	89
Total, serious adverse events	GI262570 1.0 mg	6	88

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.

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The record and each of its lists are JSON, twenty rows a page. No key.

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