Impact on Morbidity and Mortality of Prophylactic Dosing of Low Molecular Heparin in Child-Pugh B Cirrhotic Patients

NCT02271295 | Suspended Phase 3 DMC

• 2 other identifiers: P130926AOM 13606
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Thrombosis occurring in the small intrahepatic, as well as in the large vessels is involved in the progression of cirrhosis. Anticoagulation could reduce morbidity and mortality in cirrhotic patients

Conditions

Cirrhosis

Keywords

Cirrhosis; Child B; decompensation; mortality; portal thrombosis; anticoagulation

Outcome Measures

Primary Outcomes (1)

• Morbidity and mortality at 24 months

  To compare the effect of a 2-year low dosing of Enoxaparin (4000 IU/day) versus no treatment on morbidity and mortality in patients with Child B7-C10 cirrhosis.

  24 months

Secondary Outcomes (7)

• Mortality liver-related or not at 24 months

  24 months

• Adverse events at 24 months

  24 months

• Liver function and fibrosis at 24 months

  24 months

• Thrombosis at 24 months

  24 months

• Compliance

  24 months

Study Arms (2)

Enoxaparine

EXPERIMENTAL

69 Child Pugh B7-C10, cirrhotic patients receiving anticoagulation treatment (daily subcutaneous injection of enoxaparin 4000UI/day) during 24 months

Drug: Enoxaparine

Control

NO INTERVENTION

69 Child Pugh B7-C10, cirrhotic patients not receiving anticoagulation treatment

Interventions

Enoxaparine DRUG

Enoxaparine 4000UI/day during 24 months

Also known as: LOVENOX® 4000UI/day

Enoxaparine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 and ≤75 years old
• A diagnosis of cirrhosis based on liver biopsy or on the combination of clinical, laboratory and imaging criteria
• Compensated Child-Pugh B7-C10
• Any of the following causal factors : past but controlled excessive alcohol intake (\<30g/d for men and \<20g/d for women), HCV infection without viral replication, HBV infection without viral replication on therapy, metabolic syndrome, biliary cirrhosis, auto-immune cirrhosis, hemochromatosis, cryptogenetic cirrhosis

You may not qualify if:

• Ascites, portal hypertensive bleeding or encephalopathy within the last 3 months prior to enrolment
• Hepatocellular carcinoma non considered in remission
• Budd Chiari syndrome non considered in remission
• Liver transplantation
• F2 or F3 varices without treatment in accordance with recommended guidelines (B-blockers, ligation or both)
• Portal vein thrombosis
• Transjugular intrahepatic portosystemic shunt
• Known extra-hepatic malignancies
• PT\<35%
• Platelet count\<50,000/mm3
• Haemoglobin level \< 9g/dl
• Serum Albumin \< 20g/L
• A bone mineral density T score of less than -4.0 at the lumbar spine or total hip
• Known HIV infection
• Ongoing anticoagulation or antiaggregation

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Saint Antoine

Paris, France

Location

MeSH Terms

Conditions

Fibrosis

Interventions

Enoxaparin

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Armelle Poujol-Robert

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2014
• First Posted: October 22, 2014
• Study Start: July 27, 2015
• Primary Completion: July 2, 2019
• Study Completion: July 2, 2019
• Last Updated: February 27, 2018

Record last verified: 2018-02

Locations

FR (1)