Evidence map›Paper›PMID 27862178›Full record

Trial reportBritish journal of clinical pharmacology2017

Tolerability, pharmacokinetics and antiviral activity of rHSA/IFNα2a for the treatment of chronic hepatitis B infection.

Yanhua Ding, Jinfeng Lou, Hong Chen, Xiaojiao Li, Min Wu, Cuiyun Li, Jingrui Liu, Chengjiao Liu, Qingmei Li, Hong Zhang and 1 more

Open access · bronzeAbstract readClinical Trial, Phase IComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in British journal of clinical pharmacology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.5field-weighted citation impact, top 28% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 5 citations in OpenAlex.

  1. Identification ofFrontiers in immunology · 2018
    Trial
  2. Trial
  3. Article
  4. Article
  5. When Hepatitis B Virus Meets Interferons.Frontiers in microbiology · 2018
    Review
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

11 authors at 2 institutions in 1 country.

Yanhua DingPhase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China.
Jinfeng LouPhase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China.
Hong ChenPhase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China.
Xiaojiao LiPhase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China.
Min WuPhase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China.
Cuiyun LiPhase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China.
Jingrui LiuPhase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China.
Chengjiao LiuPhase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China.
Qingmei LiPhase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China.
Hong ZhangPhase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China.
Junqi NiuPhase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China.
Jilin University · CNFirst Hospital of Jilin University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsA recombinant human serum albumin-interferon alpha2a fusion protein (rHSA/IFNα2a) is expected to extend the half-life of IFNα2a. This study aims to evaluate the tolerability, safety and efficacy of rHSA/IFNα2a.

methodsThis is an open, randomized, positive control, multiple-dose ascending Phase Ib study. A panel of 32 treatment naïve and non-cirrhotic chronic hepatitis B patients were divided into four cohorts, and each received 600, 750 or 900 μg of rHSA/IFNα2a or 180 μg of PEG-IFNα2a for 3 months. Tolerability, pharmacokinetics and antiviral responses were assessed.

resultsThirty-one of 32 enrolled patients completed the treatment study. The rHSA/IFNα2a treatment was better tolerated than the PEG-IFNα2a 180 μg treatment, as evidenced by blood cell counts and higher serum albumin levels. Half-life (t

conclusionsThe rHSA/IFNα2a treatment was well tolerated and can be administered biweekly. Similar efficacy in inhibiting HBV replication was observed in both PEG-IFNα2a and rHSA/IFNα2a 750 μg groups.

Indexed as

AdultAntiviral AgentsDNA, ViralDrug Administration ScheduleFemaleHalf-LifeHepatitis B, ChronicHumansInterferon-alphaInterferon alpha-2MaleMiddle AgedPolyethylene GlycolsRecombinant Fusion ProteinsRecombinant ProteinsSerum Albumin, HumanAntiviral AgentsDNA, ViralInterferon-alphaInterferon alpha-2peginterferon alfa-2aPolyethylene GlycolsRecombinant Fusion ProteinsRecombinant ProteinsSerum Albumin, Humanalbumin-interferonantiviral responsesHBVpharmacokinetics

Identifiers

PMID27862178
PMCPMC5401974
OpenAlexW2549716744

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.