ClinicalTrials.gg
CompletedNCT02138253POLT-HCV-SVRUpdated Dec 11, 2019Results posted

A Trial of IDN-6556 in Post Orthotopic Liver Transplant for Chronic HCV

A Phase 2 interventional study of IDN-6556 and Placebo in Liver Fibrosis, Hepatic Fibrosis and Liver Cirrhosis, sponsored by Conatus Pharmaceuticals Inc.. Completed at 35 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-11.

Sponsored by Conatus Pharmaceuticals Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a double-blind, multicenter study involving patients with chronic HCV infection who had a liver transplantation; developed HCV-related liver fibrosis and/or incomplete cirrhosis; achieved a sustained virologic response (SVR) following anti-HCV therapy; but still have fibrosis and/or incomplete cirrhosis on liver biopsy to see if treatment with IDN-6556 is better than placebo in reversing or stopping the progression of the damage to the new liver caused by HCV.

Read the detailed description

There are data to suggest that with eradication of the HCV virus, improvements in liver fibrosis can be seen in the post-transplant population. However, amelioration of inflammatory activity, and deceleration of fibrosis progression is a gradual process over the course of many years. This placebo-controlled study is designed to evaluate the effects of IDN-6556, compared to placebo, on markers of apoptosis and inflammation, and liver histology.

02

Conditions studied

  • Liver Fibrosis
  • Hepatic Fibrosis
  • Liver Cirrhosis
  • Hepatic Cirrhosis

Keywords

  • liver transplant
  • hepatitis C
  • liver fibrosis
  • hepatic fibrosis
  • liver cirrhosis
  • hepatic cirrhosis
03

In context

Liver Cirrhosis

1,668 studies on the registry are indexed under Liver Cirrhosis; 360 are open to participants now.

This study's enrollment of 64 is below the median of 72 across 1,003 interventional studies indexed under Liver Cirrhosis.

Browse Liver Cirrhosis studies →

Lead sponsor

Conatus Pharmaceuticals Inc. is the lead sponsor of 17 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male or female subjects of minimum adult legal age (according to local laws for signing the informed consent document), able to provide written informed consent, and able to understand and willing to comply with the requirements of the study
  • History of orthotopic liver transplantation for HCV-induced liver disease
  • Diagnosis of HCV infection (HCV-RNA detectable in serum) and liver fibrosis and/or incomplete cirrhosis status post liver transplantation, and achieved a sustained virologic response (SVR) with anti-viral HCV treatment within 18 months of Day 1
  • Liver fibrosis on liver histology as read by central histopathologist of Ishak F2 to F6 within three months of Day 1 (Up to 15 subjects with an Ishak score of F6 can be enrolled)
  • Willingness to utilize two reliable forms of contraception (for both males and females of childbearing potential) from Screening to one month after the last dose of study drug

Exclusion criteria

Exclusion Criteria:

  • Known infection with hepatitis B virus (HBV) and/or human immunodeficiency virus (HIV)
  • History of renal transplant and/or severe renal impairment defined as eGFR (estimated glomerular filtration rate) of less than 30 mL/min/1.73 m2
  • Evidence of tumor burden >Milan criteria, or evidence of micro- or macrovascular invasion in explanted liver
  • Hepatocellular carcinoma (HCC) at entry into the study
  • Concurrent sirolimus (rapamycin) use
  • History or presence of clinically concerning cardiac arrhythmias, or prolongation of Screening (pre-treatment) QT or QTc interval of > 480 milliseconds (msec)
  • Subjects with diagnosed or suspected systemic lupus erythematosus (SLE) and/or rheumatoid arthritis (RA)
  • If female: known pregnancy, positive urine or serum pregnancy test, or lactating/breastfeeding
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
64 participants (actual)

Study arms

  • Experimental
    IDN-6556

    IDN-6556 25 mg BID

    Drug: IDN-6556

  • Placebo comparator
    Placebo

    Placebo BID

    Drug: Placebo

Interventions

  • Also known as: emricasan, PF-03491390

  • DrugPlacebo

    Placebo control

06

What researchers measure

Primary outcomes

  1. Number of Participants With At Least a One Stage Reduction From Baseline in Ishak Fibrosis Score

    At least a one stage reduction from baseline in Ishak Fibrosis Stage. Score F0 No fibrosis F1 Fibrous expansion of some portal areas, with or without short fibrous septa F2 Fibrous expansion of most portal areas, with or without short fibrous septa F3 Fibrous expansion of most portal areas, with occasional portal to portal bridging F4 Fibrous expansion of portal areas, with marked bridging (portal to portal as well as portal to central) F5 Marked bridging (portal to portal and/or portal to central) with occasional nodules (incomplete cirrhosis) F6 Cirrhosis probable or definite Since the primary analysis used multiple imputation methodology, the numerator and denominator varied across 20 imputations.

    Time frame: 24 months

Secondary outcomes

  1. Number of Participants With At Least a One Stage Reduction From Baseline in Ishak Fibrosis Score (Observed Cases Only)

    At least a one stage reduction from baseline in Ishak Fibrosis Stage. Score F0 No fibrosis F1 Fibrous expansion of some portal areas, with or without short fibrous septa F2 Fibrous expansion of most portal areas, with or without short fibrous septa F3 Fibrous expansion of most portal areas, with occasional portal to portal bridging F4 Fibrous expansion of portal areas, with marked bridging (portal to portal as well as portal to central) F5 Marked bridging (portal to portal and/or portal to central) with occasional nodules (incomplete cirrhosis) F6 Cirrhosis probable or definite

    Time frame: 24 months

  2. Number of Participants With At Least a One Stage Reduction From Baseline in Ishak Fibrosis Score

    At least a one stage reduction from baseline in Ishak Fibrosis Stage. Score F0 No fibrosis F1 Fibrous expansion of some portal areas, with or without short fibrous septa F2 Fibrous expansion of most portal areas, with or without short fibrous septa F3 Fibrous expansion of most portal areas, with occasional portal to portal bridging F4 Fibrous expansion of portal areas, with marked bridging (portal to portal as well as portal to central) F5 Marked bridging (portal to portal and/or portal to central) with occasional nodules (incomplete cirrhosis) F6 Cirrhosis probable or definite

    Time frame: 12 months

  3. Alanine Aminotransferase (ALT) - Change From Baseline

    Liver function laboratory parameter

    Time frame: Baseline and 24 months

  4. Aspartate Aminotransferase (AST) Change From Baseline

    Liver function laboratory parameter

    Time frame: Baseline and 24 months

  5. Caspase 3/7 Change From Baseline

    Mechanistic biomarker of liver function

    Time frame: Baseline and 24 months

  6. cCK18/M30 Change From Baseline

    Mechanistic biomarker of liver function.

    Time frame: Baseline and 24 months

  7. flCK18/M65 Change From Baseline

    Mechanistic biomarker of liver function

    Time frame: Baseline and 24 months

  8. Ishak Modification of Knodell Histological Activity Index - Interface Hepatitis

    The Ishak modification of Knodell histological activity index was determined by liver biopsy. Interface hepatitis * 0 = None * 1 = Mild (local, few portal areas) * 2 = Mild/moderate (focal, most portal areas) * 3 = Moderate (continuous around \<50% of tracts or septa) * 4 = Severe (continuous around \>50% of tracts or septa)

    Time frame: 24 months

  9. Ishak Modification of Knodell Histological Index - Confluent Necrosis

    The Ishak modification of Knodell histological activity index will be determined by liver biopsy. The four items and their categorizations scores include: • confluent necrosis * 0 = None * 1 = Focal confluent necrosis * 2 = Zone 3 necrosis in some areas * 3 = Zone 3 necrosis in most areas * 4 = Zone 3 necrosis + occasional portal-central bridging * 5 = Zone 3 necrosis + multiple portal-central bridging * 6 = Panacinar or multiacinar necrosis

    Time frame: 24 months

  10. Ishak Modification of Knodell Histological Index - Parenchymal Injury

    The Ishak modification of Knodell histological activity index will be determined by liver biopsy. • parenchymal injury (focal lytic necrosis, apoptosis and focal inflammation) * 0 = None * 1 = One focus or less per 10× objective * 2 = Two to four foci per 10× objective * 3 = Five to ten foci per 10× objective * 4 = More than ten foci per 10× objective

    Time frame: 24 months

  11. Ishak Modification of Knodell Histological Index - Portal Inflammation

    Portal inflammation * 0 = None * 1 = Mild, some or all portal areas * 2 = Moderate, some or all portal areas * 3 = Moderate/marked, all portal areas * 4 = Marked, all portal areas

    Time frame: 24 months

07

Results

Posted Dec 11, 2019
Limitations and caveats
The broad range of fibrosis stages included in the study and the high placebo response rates especially in the F2 and F6 fibrosis stages impacted the primary endpoint of improvement in fibrosis score from baseline.

Participant flow

Subjects were enrolled from 20 of 35 US sites that obtained IRB approval. First subject randomized Sep 2014, last subject last visit was 15 Feb 2018. A total of 114 subjects were screened, 64 subjects randomized with 41 subjects randomized to emricasan and 23 subjects randomized to placebo. Thirteen subjects discontinued the study.

Participant flow — Overall Study
MilestoneIDN-6556Placebo
Started4123
Completed3219
Not completed94
Withdrew: Adverse event33
Withdrew: Lost to follow-up21
Withdrew: Physician decision20
Withdrew: Non compliance10
Withdrew: Withdrawal by subject10

Outcome measures

PrimaryNumber of Participants With At Least a One Stage Reduction From Baseline in Ishak Fibrosis Score

At least a one stage reduction from baseline in Ishak Fibrosis Stage. Score F0 No fibrosis F1 Fibrous expansion of some portal areas, with or without short fibrous septa F2 Fibrous expansion of most portal areas, with or without short fibrous septa F3 Fibrous expansion of most portal areas, with occasional portal to portal bridging F4 Fibrous expansion of portal areas, with marked bridging (portal to portal as well as portal to central) F5 Marked bridging (portal to portal and/or portal to central) with occasional nodules (incomplete cirrhosis) F6 Cirrhosis probable or definite Since the primary analysis used multiple imputation methodology, the numerator and denominator varied across 20 imputations.

Time frame:
24 months
Reported as:
Number · participants
Number of Participants With At Least a One Stage Reduction From Baseline in Ishak Fibrosis Score
participantsIDN-6556Placebo
Number of Participants With At Least a One Stage Reduction From Baseline in Ishak Fibrosis Score2514
Statistical analysis
  • IDN-6556 vs Placebo · Cochran-Mantel-Haenszel · p = 0.73 (Stratified by baseline Ishak Fibrosis Score strata (F2, F3+F4+F5, and F6).) · Risk difference (rd): 2.9 · 95% CI -20.5 to 26.4
SecondaryNumber of Participants With At Least a One Stage Reduction From Baseline in Ishak Fibrosis Score (Observed Cases Only)

At least a one stage reduction from baseline in Ishak Fibrosis Stage. Score F0 No fibrosis F1 Fibrous expansion of some portal areas, with or without short fibrous septa F2 Fibrous expansion of most portal areas, with or without short fibrous septa F3 Fibrous expansion of most portal areas, with occasional portal to portal bridging F4 Fibrous expansion of portal areas, with marked bridging (portal to portal as well as portal to central) F5 Marked bridging (portal to portal and/or portal to central) with occasional nodules (incomplete cirrhosis) F6 Cirrhosis probable or definite

Time frame:
24 months
Reported as:
Count of participants · Participants
Number of Participants With At Least a One Stage Reduction From Baseline in Ishak Fibrosis Score (Observed Cases Only)
ParticipantsIDN-6556Placebo
Number of Participants With At Least a One Stage Reduction From Baseline in Ishak Fibrosis Score (Observed Cases Only)2514
Statistical analysis
  • IDN-6556 vs Placebo · Cochran-Mantel-Haenszel · p = 0.658 · Risk difference (rd): 4.4 · 95% CI -20.0 to 28.9
SecondaryNumber of Participants With At Least a One Stage Reduction From Baseline in Ishak Fibrosis Score

At least a one stage reduction from baseline in Ishak Fibrosis Stage. Score F0 No fibrosis F1 Fibrous expansion of some portal areas, with or without short fibrous septa F2 Fibrous expansion of most portal areas, with or without short fibrous septa F3 Fibrous expansion of most portal areas, with occasional portal to portal bridging F4 Fibrous expansion of portal areas, with marked bridging (portal to portal as well as portal to central) F5 Marked bridging (portal to portal and/or portal to central) with occasional nodules (incomplete cirrhosis) F6 Cirrhosis probable or definite

Time frame:
12 months
Reported as:
Count of participants · Participants
Number of Participants With At Least a One Stage Reduction From Baseline in Ishak Fibrosis Score
ParticipantsIDN-6556Placebo
Number of Participants With At Least a One Stage Reduction From Baseline in Ishak Fibrosis Score2717
Statistical analysis
  • IDN-6556 vs Placebo · Cochran-Mantel-Haenszel · p = 0.421 · Risk difference (rd): -7.9 · 95% CI -28.8 to 13.1
SecondaryAlanine Aminotransferase (ALT) - Change From Baseline

Liver function laboratory parameter

Time frame:
Baseline and 24 months
Reported as:
Mean · U/L
Alanine Aminotransferase (ALT) - Change From Baseline
U/LIDN-6556Placebo
Alanine Aminotransferase (ALT) - Change From Baseline-3.7 ± 1043.7 ± 239.5
SecondaryAspartate Aminotransferase (AST) Change From Baseline

Liver function laboratory parameter

Time frame:
Baseline and 24 months
Reported as:
Mean · U/L
Aspartate Aminotransferase (AST) Change From Baseline
U/LIDN-6556Placebo
Aspartate Aminotransferase (AST) Change From Baseline-4.0 ± 8.531.4 ± 161.8
SecondaryCaspase 3/7 Change From Baseline

Mechanistic biomarker of liver function

Time frame:
Baseline and 24 months
Reported as:
Mean · Raw RLU
Caspase 3/7 Change From Baseline
Raw RLUIDN-6556Placebo
Caspase 3/7 Change From Baseline-296.1 ± 830.32081.2 ± 10116.4
SecondarycCK18/M30 Change From Baseline

Mechanistic biomarker of liver function.

Time frame:
Baseline and 24 months
Reported as:
Mean · U/L
cCK18/M30 Change From Baseline
U/LIDN-6556Placebo
cCK18/M30 Change From Baseline-104.7 ± 193.2-66.1 ± 176.9
SecondaryflCK18/M65 Change From Baseline

Mechanistic biomarker of liver function

Time frame:
Baseline and 24 months
Reported as:
Mean · U/L
flCK18/M65 Change From Baseline
U/LIDN-6556Placebo
flCK18/M65 Change From Baseline-70.2 ± 189.0-98.6 ± 311.7
SecondaryIshak Modification of Knodell Histological Activity Index - Interface Hepatitis

The Ishak modification of Knodell histological activity index was determined by liver biopsy. Interface hepatitis * 0 = None * 1 = Mild (local, few portal areas) * 2 = Mild/moderate (focal, most portal areas) * 3 = Moderate (continuous around \<50% of tracts or septa) * 4 = Severe (continuous around \>50% of tracts or septa)

Time frame:
24 months
Reported as:
Count of participants · Participants
Ishak Modification of Knodell Histological Activity Index - Interface Hepatitis
ParticipantsIDN-6556Placebo
Interface Hepatitis Score of 065
Interface Hepatitis Score of 1144
Interface Hepatitis Score of 286
Interface Hepatitis Score of 331
Interface Hepatitis Score of 413
Missing Interface Hepatitis Score94
SecondaryIshak Modification of Knodell Histological Index - Confluent Necrosis

The Ishak modification of Knodell histological activity index will be determined by liver biopsy. The four items and their categorizations scores include: • confluent necrosis * 0 = None * 1 = Focal confluent necrosis * 2 = Zone 3 necrosis in some areas * 3 = Zone 3 necrosis in most areas * 4 = Zone 3 necrosis + occasional portal-central bridging * 5 = Zone 3 necrosis + multiple portal-central bridging * 6 = Panacinar or multiacinar necrosis

Time frame:
24 months
Reported as:
Count of participants · Participants
Ishak Modification of Knodell Histological Index - Confluent Necrosis
ParticipantsIDN-6556Placebo
Confluent necrosis score of 03219
Missing confluent necrosis score94
SecondaryIshak Modification of Knodell Histological Index - Parenchymal Injury

The Ishak modification of Knodell histological activity index will be determined by liver biopsy. • parenchymal injury (focal lytic necrosis, apoptosis and focal inflammation) * 0 = None * 1 = One focus or less per 10× objective * 2 = Two to four foci per 10× objective * 3 = Five to ten foci per 10× objective * 4 = More than ten foci per 10× objective

Time frame:
24 months
Reported as:
Count of participants · Participants
Ishak Modification of Knodell Histological Index - Parenchymal Injury
ParticipantsIDN-6556Placebo
Parenchymal Injury Score of 012
Parenchymal Injury Score of 1229
Parenchymal Injury Score of 257
Parenchymal Injury Score of 341
Missing Parenchymal Injury Score94
SecondaryIshak Modification of Knodell Histological Index - Portal Inflammation

Portal inflammation * 0 = None * 1 = Mild, some or all portal areas * 2 = Moderate, some or all portal areas * 3 = Moderate/marked, all portal areas * 4 = Marked, all portal areas

Time frame:
24 months
Reported as:
Count of participants · Participants
Ishak Modification of Knodell Histological Index - Portal Inflammation
ParticipantsIDN-6556Placebo
Portal Inflammation Score of 1114
Portal Inflammation Score of 2198
Portal Inflammation Score of 326
Portal Inflammation Score of 401
Missing Portal Inflammation Score94

Adverse events

Collected over Treatment emergent adverse events were collected from the first day of study drug administration until the subject's last study follow-up visit. All treatment emergent adverse events were collected up to the subsequent follow-up visit of the month 24 month visit.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
IDN-65560/41 (0%)0/41 (0%)37/41 (90.2%)
Placebo1/23 (4.3%)1/23 (4.3%)20/23 (87%)
Most frequent serious events
Most frequent serious events
EventIDN-6556Placebo
DeathNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/411/23
Most frequent other events
Most frequent other events
EventIDN-6556Placebo
FatigueGeneral disorders8/416/23
DiarrheaGastrointestinal disorders9/415/23
NauseaGastrointestinal disorders7/415/23
HypertensionVascular disorders6/414/23
ArthralgiaMusculoskeletal and connective tissue disorders6/412/23
Abdominal painGastrointestinal disorders4/412/23

Baseline characteristics

Subjects who underwent orthotopic liver transplantation for chronic HCV, developed HCV-related liver fibrosis or cirrhosis, achieved a SVR with anti-viral treatment and had demonstrable fibrosis or cirrhosis on liver histology were enrolled.

Age, Categorical
Age, Categorical(Participants)IDN-6556PlaceboTotal
<=18 years000
Between 18 and 65 years291746
>=65 years12618
Sex: Female, Male
Sex: Female, Male(Participants)IDN-6556PlaceboTotal
Female9514
Male321850
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)IDN-6556PlaceboTotal
Hispanic or Latino10616
Not Hispanic or Latino311748
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)IDN-6556PlaceboTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American729
White302050
More than one race101
Unknown or Not Reported314
Region of Enrollment
Region of Enrollment(participants)IDN-6556PlaceboTotal
United States412364
Baseline Ishak Fibrosis Score
Baseline Ishak Fibrosis Score(participants)IDN-6556PlaceboTotal
Baseline Ishak Fibrosis Score F29615
Baseline Ishak Fibrosis Score F320727
Baseline Ishak Fibrosis Score F45510
Baseline Ishak Fibrosis Score F5224
Baseline Ishak Fibrosis Score F6538
08

Study locations

35 sites
  • Southern California Research Center
    Coronado, California 92118, United States
  • Scripps Clinic
    La Jolla, California 92037, United States
  • Loma Linda University Medical Center
    Loma Linda, California 92354, United States
  • UCLA Pfleger Liver Institute
    Los Angeles, California 90095, United States
  • Georgetown University Hospital
    Washington D.C., District of Columbia 20007, United States
  • Johns Hopkins Sibley Memorial Hospital
    Washington D.C., District of Columbia 21287, United States
  • University of Florida
    Gainesville, Florida 32610, United States
  • University of Miami
    Miami, Florida 33136, United States
  • Piedmont Atlanta Hospital
    Atlanta, Georgia 30309, United States
  • Rush University Medical Center
    Chicago, Illinois 60612, United States
  • University of Chicago Medicine
    Chicago, Illinois 60637, United States
  • Indiana University
    Indianapolis, Indiana 46202, United States
  • University of Kansas Medical Center
    Kansas City, Kansas 66160, United States
  • University of Louisville
    Louisville, Kentucky 40202, United States
  • Tulane Health Science Center
    New Orleans, Louisiana 70112, United States
  • Ochsner Clinic
    New Orleans, Louisiana 70121, United States
  • John Hopkins Hospital
    Baltimore, Maryland 21287, United States
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02215, United States
  • Henery Ford Health System
    Detroit, Michigan 48202, United States
  • Saint Louis University
    St Louis, Missouri 63104, United States
  • Rutgers New Jersey Medical School
    Newark, New Jersey 07103, United States
  • Columbia University Medical Center
    New York, New York 10032, United States
  • University of Cincinnati Physicians Company
    Cincinnati, Ohio 45267, United States
  • University of Pennsylvania Milton Hershey Hospital
    Philadelphia, Pennsylvania 19104, United States
  • Temple University Hospital
    Philadelphia, Pennsylvania 19140, United States
  • Albert Einstein Medical Center
    Philadelphia, Pennsylvania 19141, United States
  • Baylor All Saints Medical Center
    Fort Worth, Texas 76104, United States
  • Liver Associates of Texas, PA
    Houston, Texas 77030, United States
  • University of Texas Health Science Center at Houston
    Houston, Texas 77030, United States
  • VAMC/Baylor College of Medicine
    Houston, Texas 77030, United States
  • University of Utah
    Salt Lake City, Utah 84132, United States
  • Bon Secours Mary Immaculate Hospital
    Newport News, Virginia 23602, United States
  • Bon Secours St. Mary's Hospital of Richmond
    Richmond, Virginia 23226, United States
  • McGuire DVAMC
    Richmond, Virginia 23249, United States
  • University of Washington Harborview Medical Center
    Seattle, Washington 98104, United States
09

References and documents

Study documents

  • Study protocol · Aug 3, 2015
  • Statistical analysis plan · Jan 18, 2018

Documents are hosted by the registry — open the source record to download them.

10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2014, a primary completion of Feb 2018 and a completion of Mar 2018. It does not say whether these dates are actual or estimated.

Results were first posted in Dec 2019, 1 year 9 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
May 12, 2014
First posted
May 14, 2014
Start
May 2014
Primary completionActual
Feb 15, 2018
CompletionActual
Mar 9, 2018
Results first posted
Dec 11, 2019
Last update
Dec 11, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 11, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02138253
Lead sponsor
Conatus Pharmaceuticals Inc.
Responsible party
Sponsor
First posted
May 14, 2014
Start date
May 2014
Primary completion
Feb 15, 2018
Completion
Mar 9, 2018
Results posted
Dec 11, 2019
Last update
Dec 11, 2019

Study contacts

David Hagerty, MD
study chair · Conatus Pharmaceuticals Inc.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Emricasan

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