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NCT03059446

Rollover Study of Cenicriviroc for the Treatment of Liver Fibrosis in Participants With Nonalcoholic Steatohepatitis

Terminated Phase 2 Results posted Last updated 2 February 2022
What this trial tests

Phase 2 trial testing Cenicriviroc in Nonalcoholic Steatohepatitis in 167 participants. Terminated before completion.

Timeline
14 February 2017
Primary endpoint
5 January 2021
5 January 2021

Quick facts

Lead sponsorTobira Therapeutics, Inc.
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment167
Start date14 February 2017
Primary completion5 January 2021
Estimated completion5 January 2021
Sites71 locations across France, Hong Kong, Italy, Belgium, United Kingdom, Germany, Poland, Puerto Rico

Drugs / interventions tested

Conditions studied

Sponsor

Tobira Therapeutics, Inc. — full company profile →

Who can join

Adults 18 to 75, any sex, with Nonalcoholic Steatohepatitis or Liver Cirrhosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Treatment-emergent Adverse Events (AE) Primary · Day 1 until the study was terminated (up to approximately 4 years)

An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. A treatment-emergent AE is an AE that occurs after a participant receives study drug.

GroupValue95% CI
Cenicriviroc (CVC) 150 mg140

Adverse events — posted to ClinicalTrials.gov

Time frame: Day 1 until the study was terminated (Up to approximately 4 years). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cenicriviroc (CVC) 150 mg
Serious: 40/167 (24%)
Deaths: 1/167

Serious adverse events (58 terms)

ReactionSystemCenicriviroc (CVC) 150 mg
Angina pectorisCardiac disorders
CellulitisInfections and infestations
DehydrationMetabolism and nutrition disorders
Acute kidney injuryRenal and urinary disorders
Cholecystitis acuteHepatobiliary disorders
Pneumonia legionellaInfections and infestations
SepsisInfections and infestations
Basal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's diseaseNeoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute coronary syndromeCardiac disorders
Angina unstableCardiac disorders
Atrial fibrillationCardiac disorders
Coronary artery occlusionCardiac disorders
TachycardiaCardiac disorders
VertigoEar and labyrinth disorders
Retinal artery occlusionEye disorders
Abdominal pain upperGastrointestinal disorders
Food poisoningGastrointestinal disorders
PancreatitisGastrointestinal disorders
Salivary gland calculusGastrointestinal disorders
VomitingGastrointestinal disorders
AstheniaGeneral disorders
CholecystitisHepatobiliary disorders
Bone abscessInfections and infestations
COVID-19 pneumoniaInfections and infestations
Other adverse events (16 terms — click to expand)

ReactionSystemCenicriviroc (CVC) 150 mg
ArthralgiaMusculoskeletal and connective tissue disorders
DiarrhoeaGastrointestinal disorders
NasopharyngitisInfections and infestations
InfluenzaInfections and infestations
NauseaGastrointestinal disorders
RashSkin and subcutaneous tissue disorders
Abdominal painGastrointestinal disorders
Abdominal pain upperGastrointestinal disorders
ConstipationGastrointestinal disorders
BronchitisInfections and infestations
Diabetes mellitusMetabolism and nutrition disorders
FatigueGeneral disorders
Alanine aminotransferase increasedInvestigations
SinusitisInfections and infestations
Upper respiratory tract infectionInfections and infestations
CoughRespiratory, thoracic and mediastinal disorders

Most-reported serious reactions: Angina pectoris, Cellulitis, Dehydration, Acute kidney injury, Cholecystitis acute, Pneumonia legionella, Sepsis, Basal cell carcinoma.

Data from ClinicalTrials.gov NCT03059446 adverse events section.

Sponsor's own description

This rollover study will provide open-label treatment with cenicriviroc and will assess the long-term safety of continued treatment with cenicriviroc in participants who participated in either the CENTAUR study 652-2-203 \[NCT02217475\] or the AURORA study \[NCT03028740\].

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Fibrosis: from mechanisms to medicines.
    Henderson NC, Rieder F, Wynn TA. · · 2020 · cited 1393× · PMID 33239795 · DOI 10.1038/s41586-020-2938-9
  2. Targeting Macrophage-Recruiting Chemokines as a Novel Therapeutic Strategy to Prevent the Progression of Solid Tumors.
    Argyle D, Kitamura T. · · 2018 · cited 149× · PMID 30483271 · DOI 10.3389/fimmu.2018.02629
  3. Therapeutic targets, novel drugs, and delivery systems for diabetes associated NAFLD and liver fibrosis.
    Kumar V, Xin X, Ma J, Tan C, et al · · 2021 · cited 128× · PMID 34314787 · DOI 10.1016/j.addr.2021.113888
  4. Cellular rejuvenation: molecular mechanisms and potential therapeutic interventions for diseases.
    Ji S, Xiong M, Chen H, Liu Y, et al · · 2023 · cited 89× · PMID 36918530 · DOI 10.1038/s41392-023-01343-5
  5. Anti-fibrotic treatments for chronic liver diseases: The present and the future.
    Odagiri N, Matsubara T, Sato-Matsubara M, Fujii H, et al · · 2021 · cited 42× · PMID 33317250 · DOI 10.3350/cmh.2020.0187
  6. Macrophage reprogramming for therapy.
    Bart VMT, Pickering RJ, Taylor PR, Ipseiz N. · · 2021 · cited 41× · PMID 33368269 · DOI 10.1111/imm.13300
  7. Potential Clinical Targets in Hepatopulmonary Syndrome: Lessons From Experimental Models.
    Raevens S, Fallon MB. · · 2018 · cited 31× · PMID 29729196 · DOI 10.1002/hep.30079
  8. Efficacy and safety of anti-hepatic fibrosis drugs.
    Damiris K, Tafesh ZH, Pyrsopoulos N. · · 2020 · cited 30× · PMID 33244194 · DOI 10.3748/wjg.v26.i41.6304

Verify or expand the search:

Other trials of Cenicriviroc

Trials testing the same drug.

Other recruiting trials for Nonalcoholic Steatohepatitis

Currently open trials in the same condition.

Other Tobira Therapeutics, Inc. trials

Trials by the same sponsor.

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