Keyhole Limpet Hemocyanin in Chronic Hepatitis C | NCT01509391

Studies
Keyhole Limpet Hemocyanin in Chronic Hepatitis C

NCT01509391

Sponsor

Medical University of Graz

Status

Completed

Last Update Posted

Oct 17, 2012Estimated

Enrollment

14Actual

Phase

Not Applicable

Conditions

Chronic Hepatitis C
Liver Cirrhosis

Interventions

keyhole-limpet hemocyanin

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Oct 2012Actual

Completion Date

Oct 2012Actual

First Submitted Date

Jan 9, 2012

First Submission Date that Met QC Criteria

Jan 12, 2012

First Posted Date

Jan 13, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 16, 2012

Last Update Posted Date

Oct 17, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Keyhole-limpet hemocyanine	Experimental		Drug: keyhole-limpet hemocyanin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
keyhole-limpet hemocyanin	Drug	Subcutaneous administration keyhole-limpet hemocyanin	Keyhole-limpet hemocyanine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hepatitis C viral load at week 24		24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Hepatitis c viral load at weeks 1,2,4,8,12,18,32		1,2,4,8,12,18,32 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rudolf E Stauber, MD	Medical University of Graz	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of Graz		Graz		8036	Austria

Condition Browse Module

MeSH Terms

ID	Term
D019698	Hepatitis C, Chronic
D008103	Liver Cirrhosis

Ancestor Terms

ID	Term
D006526	Hepatitis C
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C032808	keyhole-limpet hemocyanin

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided