NCT01121185

Brief Summary

The purpose of this study is to determine whether a human monoclonal antibody against Hepatitis C (MBL-HCV1) is effective in preventing detectable levels of Hepatitis C virus in patients undergoing liver transplantation due to chronic HCV infection. The study will also determine if MBL-HCV1 is effective in delaying or reducing the amount of detectable HCV in patients after transplant.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

8 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 12, 2010

Completed
20 days until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
5 years until next milestone

Results Posted

Study results publicly available

June 14, 2016

Completed
Last Updated

June 14, 2016

Status Verified

March 1, 2016

Enrollment Period

1 year

First QC Date

May 6, 2010

Results QC Date

March 14, 2016

Last Update Submit

May 5, 2016

Conditions

HCV InfectionLiver Transplantation

Keywords

Hepatitis C virus (HCV)Liver transplantationHuman Monoclonal Antibody

Outcome Measures

Primary Outcomes (1)

  • Proportion of Subjects With Detectable Serum HCV RNA at Day 42 Post-Transplantation

    Serum HCV RNA was measured by Quantitative RT-PCR

    At Day 42 post-transplantation

Secondary Outcomes (7)

  • The Incidence of Adverse Events and Treatment-Emergent Adverse Events Determined Through Medical History, Physical Examination and Laboratory Evaluation

    Through Day 56

  • Change in Serum HCV RNA Between Baseline and Day 3, 14, 28 and 42 Post-Transplantation

    Baseline and Day 3, 14, 28 and 42 Post-Transplantation

  • Histologic Evidence of Hepatitis by Histologic Activity Index (HAI) Score at Baseline and Day 42

    Baseline Day 0 and Day 42

  • Graft Function Assessed by Measurement of Biochemical and Synthetic Function at Multiple Time Points / International Normalized Ratio (INR)

    Through Day 56

  • Graft Function Assessed by Measurement of Biochemical and Synthetic Function at Multiple Time Points / Alanine Aminotransferase (ALT)

    Through Day 56

  • +2 more secondary outcomes

Study Arms (2)

MBL-HCV1

EXPERIMENTAL
Biological: MBL-HCV1

0.9% sodium chloride

PLACEBO COMPARATOR
Other: 0.9% Sodium chloride Placebo

Interventions

MBL-HCV1BIOLOGICAL

50 mg/kg MBL-HCV1, intravenous

MBL-HCV1
0.9% Sodium chloride PlaceboOTHER

0.9% sodium chloride, intravenous

Also known as: Normal Saline
0.9% sodium chloride

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient ≥ 18 years of age with documented chronic hepatitis C virus infection of genotype 1a undergoing liver transplantation from either a deceased donor or living donor.
  • Patient or legal guardian/health care proxy must have read, understood and provided written informed consent and HIPAA authorization after the nature of the study has been fully explained.

You may not qualify if:

  • Positive serology for Hepatitis B surface Antigen
  • Positive serology for HIV
  • Pregnancy or breastfeeding
  • Previous history of any organ transplant
  • Planned receipt of combined organ transplant (e.g. liver and kidney)
  • Receipt or planned receipt of immune globulin (IVIG) within 90 days of enrollment
  • History of extrahepatic malignancy and/or receiving chemotherapy within 90 days prior to enrollment with the exception of chemoembolization for hepatocellular carcinoma
  • Hepatocellular carcinoma with tumor burden outside of the Milan criteria
  • History of chronic renal insufficiency or creatinine \> 2.5 for ≥ six months
  • Personal or family history of deep venous thrombosis or pulmonary embolism
  • Receipt of liver allograft from HCV positive donor or Hepatitis B core antibody positive donor
  • Receipt of liver allograft donated after cardiac death of donor
  • Receipt of any antiviral agents, licensed or investigational for hepatitis C virus within 90 days prior to enrollment
  • Receipt of any other investigational study product within 30 days prior to enrollment
  • Any other condition that in the opinion of the investigator would jeopardize the safety or rights of the patient participating in the study or make it unlikely that the patient could complete the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Yale-New Haven Hospital

New Haven, Connecticut, 06504, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Lahey Clinic

Burlington, Massachusetts, 01805, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Methodist Healthcare Foundation

Memphis, Tennessee, 38104, United States

Location

Related Publications (1)

  • Chung RT, Gordon FD, Curry MP, Schiano TD, Emre S, Corey K, Markmann JF, Hertl M, Pomposelli JJ, Pomfret EA, Florman S, Schilsky M, Broering TJ, Finberg RW, Szabo G, Zamore PD, Khettry U, Babcock GJ, Ambrosino DM, Leav B, Leney M, Smith HL, Molrine DC. Human monoclonal antibody MBL-HCV1 delays HCV viral rebound following liver transplantation: a randomized controlled study. Am J Transplant. 2013 Apr;13(4):1047-1054. doi: 10.1111/ajt.12083. Epub 2013 Jan 28.

    PMID: 23356386RESULT

MeSH Terms

Conditions

Hepatitis C

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Results Point of Contact

Title
Director Clinical Affairs
Organization
MassBiologics
MBLclinicaldirector@umassmed.edu
617-474-3000

Study Officials

  • Deborah C. Molrine, MD

    Massbiologics of University of Massachusetts Medical School

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2010

First Posted

May 12, 2010

Study Start

June 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

June 14, 2016

Results First Posted

June 14, 2016

Record last verified: 2016-03

Locations

US(8)