NCT02326103

Brief Summary

The study is aimed to evaluate the additional role of ciprofloxacin therapy in severe alcoholic hepatitis combined to prednisolone therapy in an open-label placebo controlled manner.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Apr 2015

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 25, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

January 19, 2017

Status Verified

January 1, 2017

Enrollment Period

1.8 years

First QC Date

December 22, 2014

Last Update Submit

January 18, 2017

Conditions

Alcoholic HepatitisAlcoholic Cirrhosis

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

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:

  • Viral hepatitis Remarkable bleeding in the gastrointestinal tract Serious bacterial infection Hepatorenal syndrome Earlier participation in this study Malignant disease not in remission Other liver disease affecting remarkably the outcome of alcoholic liver disease Mental retardation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Helsinki

Helsinki, 00029HUS, Finland

Location

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 ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Perttu Sahlman, MD

    University Hospital of Helsinki

    PRINCIPAL INVESTIGATOR

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 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

January 19, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

No IPD will be shared with other researchers during the study or during the analysis of the results.

Locations

FI(1)