Trial · NCT00608894

LCP-Tacro vs. Azathioprine for the Treatment of Autoimmune Hepatitis

NCT00608894, Phase 2, Terminated, Asahi Kasei Therapeutics, Inc.; results first posted 2020-03-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. LCP-Tacro vs. Azathioprine for the Treatment of Autoimmune Hepatitis. Trials, record NCT00608894. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00608894

On this page

Trial

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

Title: LCP-Tacro vs. Azathioprine for the Treatment of Autoimmune Hepatitis
NCT number: NCT00608894
Status: Terminated
Phases: Phase 2
Enrollment: 13 participants, actual
Lead sponsor: Asahi Kasei Therapeutics, Inc.
Conditions: Autoimmune Hepatitis
Interventions: LCP-Tacro (tacrolimus), Azathioprine
First posted: 2008-02-06
Last updated: 2020-03-17
Results first posted: 2020-03-06
Limitations and caveats: The study was discontinued due to slow enrollment. Consequently, the number of patients enrolled in the study was too small to permit meaningful statistical analyses.

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Biochemical Remission of (AIH) at Month 6.	6 months	Percent of patients that achieve biochemical remission of (AIH) at Month 6 during treatment with LCP-Tacro + prednisone or azathioprine + prednisone. Biochemical remission is defined as ALT, total bilirubin and gamma globulin within normal limits.
Secondary	Biochemical Remission by Month 3.	3 months	Percent of patients who achieve biochemical remission by Month 3 during treatment with LCP-Tacro + prednisone or azathioprine + prednisone. Biochemical remission is defined as ALT, total bilirubin and gamma globulin within normal limits.
Secondary	Incomplete Response, Treatment Failure, or a Case of Relapse at 6 Months	6 months	Percents of patients in each treatment group classified as having an incomplete response (defined as some or no improvement during therapy), a treatment failure (defined as permanent discontinuation of the regimen originally randomized to), or a case of relapse (recurrence following achievement of remission)

Source ClinicalTrials.gov

Outcomes3

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Biochemical Remission of (AIH) at Month 6.	6 months	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Biochemical Remission by Month 3.	3 months	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Incomplete Response, Treatment Failure, or a Case of Relapse at 6 Months	6 months	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group10

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

Outcome	Group	Category	Value	Units
Biochemical Remission of (AIH) at Month 6.	LCP-Tacro		3	Participants
Biochemical Remission of (AIH) at Month 6.	Azathioprine		4	Participants
Biochemical Remission by Month 3.	LCP-Tacro		2	Participants
Biochemical Remission by Month 3.	Azathioprine		4	Participants
Incomplete Response, Treatment Failure, or a Case of Relapse at 6 Months	LCP-Tacro	Incomplete response	4	Participants
Incomplete Response, Treatment Failure, or a Case of Relapse at 6 Months	Azathioprine	Incomplete response	1	Participants
Incomplete Response, Treatment Failure, or a Case of Relapse at 6 Months	LCP-Tacro	Treatment failure	0	Participants
Incomplete Response, Treatment Failure, or a Case of Relapse at 6 Months	Azathioprine	Treatment failure	1	Participants
Incomplete Response, Treatment Failure, or a Case of Relapse at 6 Months	LCP-Tacro	Relapse	0	Participants
Incomplete Response, Treatment Failure, or a Case of Relapse at 6 Months	Azathioprine	Relapse	0	Participants

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	LCP-Tacro	7
Overall Study	STARTED	Azathioprine	6
Overall Study	COMPLETED	LCP-Tacro	7
Overall Study	COMPLETED	Azathioprine	4
Overall Study	NOT COMPLETED	LCP-Tacro	0
Overall Study	NOT COMPLETED	Azathioprine	2

Source ClinicalTrials.gov

Adverse events16

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	Abdominal discomfort	Gastrointestinal disorders	LCP-Tacro	1	7
other	Abdominal discomfort	Gastrointestinal disorders	Azathioprine	0	6
other	Diarrhea	Gastrointestinal disorders	LCP-Tacro	2	7
other	Diarrhea	Gastrointestinal disorders	Azathioprine	1	6
other	Nausea	Gastrointestinal disorders	LCP-Tacro	1	7
other	Nausea	Gastrointestinal disorders	Azathioprine	2	6
other	Vomiting	Gastrointestinal disorders	LCP-Tacro	1	7
other	Vomiting	Gastrointestinal disorders	Azathioprine	2	6
other	Headache	Nervous system disorders	LCP-Tacro	2	7
other	Headache	Nervous system disorders	Azathioprine	0	6

1 to 10 of 16Source ClinicalTrials.gov

See all 16 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	LCP-Tacro	0	7
Total, all-cause mortality	Azathioprine	0	6
Total, other adverse events	LCP-Tacro	6	7
Total, other adverse events	Azathioprine	5	6
Total, serious adverse events	LCP-Tacro	0	7
Total, serious adverse events	Azathioprine	0	6

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 comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
LCP-Tacro vs Azathioprine: Biochemical Remission by Month 3.	Trial comparisons
LCP-Tacro vs Azathioprine: Biochemical Remission of (AIH) at Month 6.	Trial comparisons
LCP-Tacro vs Azathioprine: deaths from any cause	Trial comparisons
LCP-Tacro vs Azathioprine: serious adverse events	Trial comparisons

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/NCT00608894

GET https://conductscience.org/api/trials/v1/NCT00608894/registered

API reference For AI assistants