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

February 10, 2012
March 19, 2014
May 2012
December 2014   (final data collection date for primary outcome measure)
Number of subjects with undetectable HCV RNA at day 56 [ Time Frame: Day 56 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01532908 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Evaluate the safety and tolerability as assessed by adverse events, concomitant medication use, physical examination, clinical laboratory evaluation [ Time Frame: Day 98 ] [ 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 ] [ Designated as safety issue: No ]
  • Evaluate the reduction in viral load as compared with pre-transplant HCV RNA levels [ Time Frame: Day 98 ] [ Designated as safety issue: No ]
  • Determine HCV resistance-associated variants to MBL-HCV1 and protease inhibitor before and after receipt of study treatment [ Time Frame: Day 98 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
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

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis C Infection
  • 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)
  • 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)
  • Experimental: Part 1: MBL-HCV1 and Telaprevir
    Interventions:
    • Biological: MBL-HCV1
    • Drug: Telaprevir (Part 1)
  • Experimental: Part 2: MBL-HCV1 and Sofosbuvir
    Interventions:
    • Biological: MBL-HCV1
    • Drug: Sofosbuvir (Part 2)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
July 2015
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: MassBiologics Clinical Affairs Director 617-474-3000
United States
 
NCT01532908
MBL-HCV1-11-03
No
MassBiologics
MassBiologics
Not Provided
Not Provided
MassBiologics
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP