NCT01509391

Brief Summary

In this study the investigators examine the safety and efficacy of Keyhole-limpet-hemocyanin in patients with chronic hepatitis c infection and liver cirrhosis. The investigators hypothesize that administration of keyhole-limpet-hemocyanin reduces the viral load in patients infected with hepatitis c.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 13, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

October 17, 2012

Status Verified

October 1, 2012

Enrollment Period

9 months

First QC Date

January 9, 2012

Last Update Submit

October 16, 2012

Conditions

Chronic Hepatitis CLiver Cirrhosis

Outcome Measures

Primary Outcomes (1)

  • Hepatitis C viral load at week 24

    24 weeks

Secondary Outcomes (1)

  • Hepatitis c viral load at weeks 1,2,4,8,12,18,32

    1,2,4,8,12,18,32 weeks

Study Arms (1)

Keyhole-limpet hemocyanine

EXPERIMENTAL
Drug: keyhole-limpet hemocyanin

Interventions

keyhole-limpet hemocyaninDRUG

Subcutaneous administration keyhole-limpet hemocyanin

Keyhole-limpet hemocyanine

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic Hepatitis C infection
  • no previous therapy
  • at least one contraindication to interferon therapy
  • liver cirrhosis
  • age between 18-80 y
  • women of not childbearing age

You may not qualify if:

  • Hypersensitivity against keyhole-limpet hemocyanin
  • previous treatment against hepatitis c
  • autoimmune disorders
  • immunosuppression
  • hepatocellular carcinoma or other malignancies
  • coinfection with hepatitis b or HIV
  • pregnancy
  • cardiovascular event during the last 6 months (stroke or MCI)
  • uncontrolled diabetes
  • renal insufficiency (GFR \< 50 ml/min) or chronic hemodialysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Graz

Graz, 8036, Austria

Location

MeSH Terms

Conditions

Hepatitis C, ChronicLiver Cirrhosis

Interventions

keyhole-limpet hemocyanin

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsFibrosis

Study Officials

  • Rudolf E Stauber, MD

    Medical University of Graz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Univ. Prof. Dr.

Study Record Dates

First Submitted

January 9, 2012

First Posted

January 13, 2012

Study Start

January 1, 2012

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

October 17, 2012

Record last verified: 2012-10

Locations

AU(1)