Evidence map›Paper›PMID 23356386›Full record

Trial reportAmerican journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons2013

Human monoclonal antibody MBL-HCV1 delays HCV viral rebound following liver transplantation: a randomized controlled study.

R T Chung, F D Gordon, M P Curry, T D Schiano, S Emre, K Corey, J F Markmann, M Hertl, J J Pomposelli, E A Pomfret and 13 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01121185 (A Phase II Randomized, Double-Blind, Placebo Controlled Study of the Clinical Effectiveness of a Human Monoclonal Antibody Against Hepatitis C Virus E2 Glycoprotein), which is not on this map. Cited by 61 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
61citing papers in PubMed, 1 pooled it
5.7field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01121185 phase2terminatednot on this map

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

TypeinterventionalSponsorMassBiologicsRan2010 to 2011Enrolled13ConditionsHCV Infection, Liver TransplantationArmsMBL-HCV1, 0.9% Sodium chloride Placebo
3 · Its place in the literature

Who cites it

61 citing papers in PubMed, 1 synthesis or guideline pooled it, 88 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Article
  6. Review
  7. Monoclonal antibody applications in travel medicine.Tropical diseases, travel medicine and vaccines · 2024
    Review
  8. Review
  9. Article
  10. Review
  11. Review
  12. Review
  13. Review
  14. Antibody Responses in Hepatitis C Infection.Cold Spring Harbor perspectives in medicine · 2021
    Review
  15. Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. Article

1 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

23 authors at 6 institutions in 1 country.

R T ChungDepartment of Transplant Surgery, Massachusetts General Hospital, Boston, MA.
F D GordonDepartment of Transplantation, Lahey Clinic Medical Center, Burlington, MA.
M P CurryBeth Israel Deaconess Medical Center, Boston, MA.
T D SchianoDepartment of Surgery, Mount Sinai Medical Center, New York, NY.
S EmreDepartment of Medicine, Yale New Haven Hospital, New Haven, CT.
K CoreyDepartment of Transplant Surgery, Massachusetts General Hospital, Boston, MA.
J F MarkmannDepartment of Transplant Surgery, Massachusetts General Hospital, Boston, MA.
M HertlDepartment of Transplant Surgery, Massachusetts General Hospital, Boston, MA.
J J PomposelliDepartment of Transplantation, Lahey Clinic Medical Center, Burlington, MA.
E A PomfretDepartment of Transplantation, Lahey Clinic Medical Center, Burlington, MA.
S FlormanDepartment of Surgery, Mount Sinai Medical Center, New York, NY.
M SchilskyDepartment of Medicine, Yale New Haven Hospital, New Haven, CT.
T J BroeringMassBiologics, University of Massachusetts Medical School, Boston, MA.
R W FinbergDepartment of Medicine, University of Massachusetts Medical School, Worcester, MA.
G SzaboDepartment of Medicine, University of Massachusetts Medical School, Worcester, MA.
P D ZamoreHoward Hughes Medical Institute and Department of Biochemistry & Molecular Pharmacology, University of Massachusetts Medical School, Worcester, MA.
U KhettryDepartment of Transplantation, Lahey Clinic Medical Center, Burlington, MA.
G J BabcockMassBiologics, University of Massachusetts Medical School, Boston, MA.
D M AmbrosinoMassBiologics, University of Massachusetts Medical School, Boston, MA.
B LeavMassBiologics, University of Massachusetts Medical School, Boston, MA.
M LeneyMassBiologics, University of Massachusetts Medical School, Boston, MA.
H L SmithMassBiologics, University of Massachusetts Medical School, Boston, MA.
D C MolrineMassBiologics, University of Massachusetts Medical School, Boston, MA.
University of Massachusetts Chan Medical School · USLahey Hospital and Medical Center · USMassachusetts General Hospital · USMount Sinai Medical Center · USYale New Haven Hospital · USBeth Israel Deaconess Medical Center · US

Funding

Mount Sinai Institutes for Clinical and Translational SciencesUL1TR000067 · NCATS · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI SAMPSON, HUGH A · 2012 to 2014
$16.5M
Patient-Oriented Research on Hepatitis in Special PopulationsK24DK078772 · NIDDK · MASSACHUSETTS GENERAL HOSPITAL · PI CHUNG, RAYMOND T · 2007 to 2016
$1.6M
NCATS NIH HHS UL1 TR000067NCATS NIH HHS UL1TR000067NIDDK NIH HHS DK078772NIDDK NIH HHS K24 DK078772
6 · The paper itself

Abstract

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.

Indexed as

Liver TransplantationAgedAntibodies, MonoclonalBiopsyDouble-Blind MethodFemaleGenotypeHepacivirusHepatitis CHumansLiverMaleMiddle AgedPilot ProjectsRNA, ViralTime FactorsAntibodies, Monoclonalglycoprotein E2, Hepatitis C virusRNA, ViralViral Envelope Proteins

Identifiers

PMID23356386
PMCPMC3618536
OpenAlexW2162909292

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.