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 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.

Start Date21 Nov 2012

Sponsor / Collaborator

MassBiologics

NCT01121185 / TerminatedPhase 2

A Phase II Randomized, Double-Blind, Placebo Controlled Study of the Clinical Effectiveness of a Human Monoclonal Antibody Against Hepatitis C Virus E2 Glycoprotein (MBL-HCV1) in Hepatitis C Infected Patients Undergoing Liver Transplantation

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.

Start Date01 Jun 2010

Sponsor / Collaborator

MassBiologics

NCT00952263 / CompletedPhase 1

Open-Label, Dose Escalation Phase I Study in Healthy Volunteers to Evaluate the Safety and Pharmacokinetics of a Human Monoclonal Antibody (MBL-HCV1) Against Hepatitis C E2 Glycoprotein

This is a phase I, open-label, dose escalation study to evaluate the safety of MBL-HCV1 in healthy adult volunteers. Eligible volunteers will be admitted to a phase 1 unit for study infusion. A single dose of human monoclonal antibody will be administered. The study duration is 56 days. During this time, safety will be assessed via physical examinations, laboratory testing, concomitant medication usage and review of treatment emergent adverse events should they occur. Pharmacokinetics will be derived from analysis of blood samples obtained during the 56 day study.

Start Date01 Jul 2009

Sponsor / Collaborator

MassBiologics

100 Clinical Results associated with MBL-HCV1

100 Translational Medicine associated with MBL-HCV1

100 Patents (Medical) associated with MBL-HCV1

Literatures (Medical) associated with MBL-HCV1

01 Apr 2013·American Journal of TransplantationQ1 · MEDICINE

Human Monoclonal Antibody MBL-HCV1 Delays HCV Viral Rebound Following Liver Transplantation: A Randomized Controlled Study

Q1 · MEDICINE

Article

Author: Hertl, M ; Gordon, F D ; Markmann, J F ; Ambrosino, D M ; Khettry, U ; Finberg, R W ; Zamore, P D ; Curry, M P ; Leney, M ; Schilsky, M ; Broering, T J ; Leav, B ; Florman, S ; Chung, R T ; Pomposelli, J J ; Babcock, G J ; Molrine, D C ; Szabo, G ; Schiano, T D ; Corey, K ; Emre, S ; Smith, H L ; Pomfret, E A

Rapid allograft infection complicates liver transplantation (LT) in patients with hepatitis C virus (HCV). Pegylated interferon-α and ribavirin therapy after LT has significant toxicity and limited efficacy. The effect of a human monoclonal antibody targeting the HCV E2 glycoprotein (MBL-HCV1) on viral clearance was examined in a randomized, double-blind, placebo-controlled pilot study in patients infected with HCV genotype 1a undergoing LT. Subjects received 11 infusions of 50 mg/kg MBL-HCV1 (n=6) or placebo (n=5) intravenously with three infusions on day of transplant, a single infusion on days 1 through 7 and one infusion on day 14 after LT. MBL-HCV1 was well-tolerated and reduced viral load for a period ranging from 7 to 28 days. Median change in viral load (log10 IU/mL) from baseline was significantly greater (p=0.02) for the antibody-treated group (range -3.07 to -3.34) compared to placebo group (range -0.331 to -1.01) on days 3 through 6 posttransplant. MBL-HCV1 treatment significantly delayed median time to viral rebound compared to placebo treatment (18.7 days vs. 2.4 days, p<0.001). As with other HCV monotherapies, antibody-treated subjects had resistance-associated variants at the time of viral rebound. A combination study of MBL-HCV1 with a direct-acting antiviral is underway.

PLoS ONEQ3 · CROSS-FIELD

High-Throughput Sequencing Analysis of Post-Liver Transplantation HCV E2 Glycoprotein Evolution in the Presence and Absence of Neutralizing Monoclonal Antibody

Q3 · CROSS-FIELD

ArticleOA

Author: Phillip D. Zamore ; Donna M. Ambrosino ; Heidi L. Smith ; Zhiping Weng ; Deborah C. Molrine ; Yang Wang ; Sowmya Iyer ; Brian G. Pierce ; Kirk Rowley ; Gregory J. Babcock

Chronic hepatitis C virus (HCV) infection is the most common cause of end-stage liver disease, often leading to liver transplantation, in which case circulating virions typically infect the transplanted liver within hours and viral concentrations can quickly exceed pre-transplant levels. MBL-HCV1 is a fully human monoclonal antibody recognizing a linear epitope of the HCV E2 envelope glycoprotein (amino acids 412-423). The ability of MBL-HCV1 to prevent HCV recurrence after liver transplantation was investigated in a phase 2 randomized clinical trial evaluating six MBL-HCV1-treated subjects and five placebo-treated subjects. MBL-HCV1 treatment significantly delayed time to viral rebound compared with placebo treatment. Here we report results from high-throughput sequencing on the serum of each of the eleven enrolled subjects prior to liver transplantation and after viral rebound. We further sequenced the sera of the MBL-HCV1-treated subjects at various interim time points to study the evolution of antibody-resistant viral variants. We detected mutations at one of two positions within the antibody epitope--mutations of N at position 415 to D, K or S, or mutation of N at position 417 to S. It has been previously reported that N415 is not glycosylated in the wild-type E2 protein, but N417S can lead to glycosylation at position 415. Thus N415 is a key position for antibody recognition and the only routes we identified for viral escape, within the constraints of HCV fitness in vivo, involve mutating or glycosylating this position. Evaluation of mutations along the entire E1 and E2 proteins revealed additional positions that changed moderately before and after MBL-HCV1 treatment for subsets of the six subjects, yet underscored the relative importance of position 415 in MBL-HCV1 resistance.

100 Deals associated with MBL-HCV1

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Hepatitis C	Phase 2	US	MassBiologics	21 Nov 2012

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01532908 (MBL-HCV1, CTgov)	Phase 2	Hepatitis C	11	MBL-HCV1+Telaprevir (Part 1) (Part 1: MBL-HCV1 and Telaprevir)	iwzwaxqmpg(kidwjwgmjf) = ldsjiyezaa rgwcovisbk (peukxaecgz, etlapyslnx - mapqdszdmn) View more	-	05 Feb 2021
				Sofosbuvir (Part 2)+MBL-HCV1 (Part 2: MBL-HCV1 and Sofosbuvir)	iwzwaxqmpg(kidwjwgmjf) = essdwjrudh rgwcovisbk (peukxaecgz, ufwgamhiqb - onylcgwxmo) View more
NCT01121185 (Pubmed \| MMWR Morb Mortal Wkly Rep)	Phase 2	-	11	MBL-HCV1	(arpodgnlbs) = eoorbiewah achlbqkvkm (yiixofatpg ) View more	-	01 Apr 2013
				Placebo	(arpodgnlbs) = vhswjpxmhq achlbqkvkm (yiixofatpg ) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

MBL-HCV1

Overview

Basic Info

Gene Sequence

Related

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation