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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by MassBiologics
Sponsor:
Information provided by (Responsible Party):
MassBiologics
ClinicalTrials.gov Identifier:
NCT01532908
First received: February 10, 2012
Last updated: March 19, 2014
Last verified: March 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Evaluate the reduction in viral load as compared with pre-transplant HCV RNA levels [ Time Frame: Day 98 to Day 126 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: May 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: December 2014 (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
Genders Eligible for Study:   Both
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 90 days prior to enrollment, except for hepatocellular carcinoma patients on treatment with sofosbuvir and ribavirin with detectable HCV RNA within 60 days of liver transplantation
  • 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

Contacts
Contact: MassBiologics Clinical Affairs Director 617-474-3000

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Jenna Gustafson    617-724-3836      
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Michael Curry, MD    617-632-9852      
United States, Missouri
Washington University School of Medicine Recruiting
St Louis, Missouri, United States, 63110
Contact: William C Chapman, M.D.    314-362-7792      
United States, New York
Mount Sinai Hospital Recruiting
New York, New York, United States, 10029
Contact: Thomas D Schiano, MD    212-241-0034      
United States, Texas
The Liver Institute at Methodist Dallas Medical Center Recruiting
Dallas, Texas, United States, 75203
Contact: Parvez Mantry, MD    214-947-4450      
Contact: Johann Correos    214-947-4451      
Sponsors and Collaborators
MassBiologics
  More Information

No publications provided

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: March 19, 2014
Health Authority: United States: Food and Drug Administration

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
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014