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Open Label Study of the Efficacy and Safety of MBL-HCV1 in Combination With Oral Direct-Acting Antivirals in Patients Undergoing Liver Transplantation for Hepatitis C (MBL-HCV1)

This study has been terminated.
(The study was terminated due to funding constraints)
Sponsor:
Information provided by (Responsible Party):
MassBiologics
ClinicalTrials.gov Identifier:
NCT01532908
First received: February 10, 2012
Last updated: April 24, 2017
Last verified: April 2017
  Purpose
The purpose of this study is to assess efficacy of a human monoclonal antibody against Hepatitis C (MBL-HCV1) combined with telaprevir [part 1: an HCV protease inhibitor] or sofosbuvir [part 2: an HCV NS5B polymerase inhibitor] in a 56 day treatment duration in patients undergoing liver transplantation due to chronic HCV infection. There is an option for extended study treatment through 84 days if viral load is undetectable at day 56.

Condition Intervention Phase
Hepatitis C Infection Biological: MBL-HCV1 Drug: Telaprevir (Part 1) Drug: Sofosbuvir (Part 2) Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase II Open-Label Study of the Clinical Effectiveness of a Human Monoclonal Antibody Against Hepatitis C Virus E2 Glycoprotein (MBL-HCV1) Combined With Oral Direct-Acting Antivirals in Hepatitis C Infected Patients Undergoing Liver Transplantation

Resource links provided by NLM:


Further study details as provided by MassBiologics:

Primary Outcome Measures:
  • Number of subjects with undetectable HCV RNA at day 56 [ Time Frame: Day 56 ]

Secondary Outcome Measures:
  • Evaluate the safety and tolerability as assessed by adverse events, concomitant medication use, physical examination, clinical laboratory evaluation [ Time Frame: Day 98 to Day 126 ]
  • Proportion of subjects with undetectable HCV RNA at multiple time points through at least 6 weeks after end of treatment [ Time Frame: Day 98 to Day 126 ]
  • Evaluate the reduction in viral load as compared with pre-transplant HCV RNA levels [ Time Frame: Day 98 to Day 126 ]
  • Determine HCV resistance-associated variants to MBL-HCV1 and oral direct-acting antivirals before and after receipt of study treatment [ Time Frame: Day 98 to Day 126 ]

Other Outcome Measures:
  • Proportion of subjects with sustained virologic response (SVR) at 12 weeks and 24 weeks post-treatment [ Time Frame: 12 weeks and 24 weeks post-treatment ]
    Exploratory Endpoint


Enrollment: 10
Study Start Date: May 2012
Study Completion Date: August 27, 2015
Primary Completion Date: August 27, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part 1: MBL-HCV1 and Telaprevir Biological: MBL-HCV1
50 mg/kg MBL-HCV1, intravenous, up to 15 infusions over 56 days; option for extended treatment through 84 days if viral load undetectable at day 56
Drug: Telaprevir (Part 1)
Two 375 mg tablets, 3 times a day up to 56 days; option for extended treatment through 84 days if viral load undetectable at day 56
Other Name: Incivek (telaprevir)
Experimental: Part 2: MBL-HCV1 and Sofosbuvir Biological: MBL-HCV1
50 mg/kg MBL-HCV1, intravenous, up to 15 infusions over 56 days; option for extended treatment through 84 days if viral load undetectable at day 56
Drug: Sofosbuvir (Part 2)
One 400 mg tablet, 1 time per day up to 56 days; option for extended treatment through 84 days if viral load undetectable at day 56
Other Name: Sovaldi (sofosbuvir)

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient ≥ 18 years of age with documented chronic hepatitis C virus infection of genotype 1 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.

Exclusion Criteria:

  • Positive 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
  • Extrahepatic malignancy not currently in remission and/or receiving systemic chemotherapy and/or radiation within 90 days prior to enrollment. Exceptions include chemoembolization for hepatocellular carcinoma or cutaneous malignancies managed with local treatment
  • Hepatocellular carcinoma with tumor burden outside of the Milan criteria
  • Serum creatinine > 2.5 for > or = six months at the time of enrollment
  • Personal or family history (first degree relative) 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 30 days prior to liver transplantation, unless patient has documented detectable HCV RNA during this 30 day period
  • Previous receipt of an HCV protease inhibitor (for subjects enrolling in Part 1: telaprevir)
  • Receipt of any other investigational study product within 30 days prior to enrollment
  • Seizure disorder requiring anti-convulsant therapy
  • Pulmonary arterial hypertension requiring sildenafil or tadalafil infusion (for subjects enrolling in Part 1: telaprevir)
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01532908

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, New York
Mount Sinai Hospital
New York, New York, United States, 10029
United States, Texas
The Liver Institute at Methodist Dallas Medical Center
Dallas, Texas, United States, 75203
Sponsors and Collaborators
MassBiologics
  More Information

Publications:
Responsible Party: MassBiologics
ClinicalTrials.gov Identifier: NCT01532908     History of Changes
Other Study ID Numbers: MBL-HCV1-11-03
Study First Received: February 10, 2012
Last Updated: April 24, 2017

Keywords provided by MassBiologics:
Liver Transplantation

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Antiviral Agents
Sofosbuvir
Anti-Infective Agents

ClinicalTrials.gov processed this record on June 23, 2017