Trials Sponsors Conditions Drugs Pricing

Conditions

Alcoholic Cirrhosis Alcoholic Hepatitis

Keywords

alcoholichepatitiscirrhosischolesterol metabolitesciprofloxacin

Outcome Measures

Primary Outcomes (3)

Death at 28 days
28 days after randomisation
Death at 3 months
3 months after randomisation
Death at 6 months
6 months after randomisation

Secondary Outcomes (2)

Early reduction in serum bilirubin level
7 days after randomisation
Surrogate markers of liver function
7 days to 12 months

Study Arms (2)

Ciprofloxacin

ACTIVE COMPARATOR

Oral administration of Ciprofloxacin 500mg twice daily

Drug: Ciprofloxacin

Placebo

PLACEBO COMPARATOR

Oral administration of Placebo pill twice daily

Drug: Placebo

Interventions

CiprofloxacinDrug

Comparison of ciprofloxacin with placebo in alcoholic hepatitis

Ciprofloxacin

PlaceboDrug

Placebo

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 64 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

Severe alcoholic hepatitis; Maddrey above 300

You may not qualify if:

Sponsors & Collaborators

University of Helsinki
Otherlead

Study Sites (1)

University Hospital of Helsinki

Helsinki, 00029HUS, Finland

MeSH Terms

Conditions

Hepatitis, AlcoholicLiver Cirrhosis, AlcoholicHepatitisFibrosis

Interventions

Ciprofloxacin

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesLiver Diseases, AlcoholicAlcohol-Induced DisordersAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersLiver CirrhosisPathologic Processes

Study Officials

Perttu Sahlman, MD
University Hospital of Helsinki
PRINCIPAL INVESTIGATOR

Enrollment

22 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: early phase 1
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: chief specialist

Study Record Dates

First Submitted

December 22, 2014

First Posted

December 25, 2014

Study Start

April 2015

Date type not reported

This date has not been verified as actual or estimated.

Randomised Open-label Multicenter Study Evaluating Ciprofloxacin in Severe Alcoholic Hepatitis

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (2)

Study Arms (2)

Ciprofloxacin

Placebo

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (2)

Study Arms (2)

Ciprofloxacin

Placebo

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations