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

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-21

Study Completion Date

2015-08-27

Brief Summary

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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 \[part 2: an Hepatitis C virus NS5B polymerase inhibitor\] 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.

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Detailed Description

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Administration of Intravenous infusions of MBL-HCV1 (50mg/kg) human monoclonal antibody during the first 14 days post-transplantation: three infusions on day 0 (1-4 hours prior to the anhepatic phase, during the anhepatic phase, and 4-12 hours post-reperfusion). Daily infusions on days 1 through 7, weekly infusions on day 14 ± 2, day 21 ± 3, and day 28 ± 3, followed by biweekly infusions on day 42 ± 3 and on day 56 ± 3 if criteria for the stopping rule are not met. For those subjects electing extended treatment, the administration of additional infusions on day 70 ± 3 and day 84 ± 3 will be performed. Subjects receive an oral direct-acting antiviral (telaprevir in Part 1 and sofosbuvir in Part 2) starting no earlier than day 3 post-transplant and no later than day 7; dosing continuing through day 56 unless criteria for the stopping rule are met. Subjects who elect to receive extended study treatment for a total of 12 weeks continue telaprevir in Part 1 or sofosbuvir in Part 2 through day 84 ± 3.

Conditions

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Hepatitis C Infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1: MBL-HCV1 and Telaprevir

Group Type EXPERIMENTAL

MBL-HCV1

Intervention Type BIOLOGICAL

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

Telaprevir (Part 1)

Intervention Type DRUG

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

Part 2: MBL-HCV1 and Sofosbuvir

Group Type EXPERIMENTAL

MBL-HCV1

Intervention Type BIOLOGICAL

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

Sofosbuvir (Part 2)

Intervention Type DRUG

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

Interventions

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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

Intervention Type BIOLOGICAL

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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Incivek (telaprevir) Sovaldi (sofosbuvir)

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No