NCT01686789

Brief Summary

The study aims to study the outcome of pharmacokinetics-adjusted dose ribavirin (plus pegIFN) on the SVR in chronic HCV patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
181

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2011

Longer than P75 for phase_4

Geographic Reach
1 country

3 active sites

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

Study Start

First participant enrolled

January 1, 2011

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 18, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

February 24, 2016

Status Verified

February 1, 2016

Enrollment Period

4.6 years

First QC Date

September 13, 2012

Last Update Submit

February 23, 2016

Conditions

Chronic Hepatitis C Virus

Outcome Measures

Primary Outcomes (1)

  • Sustained virological response

    Detectability of HCV RNA after 24 weeks of treatment completion by a realTime PCR-based technique

    72 weeks

Secondary Outcomes (1)

  • Requirement of blood-related products

    48 weeks

Study Arms (2)

Pegylated interferon alpha-2a plus standard dose ribavirin

ACTIVE COMPARATOR

Pegylated interferon alpha-2a 180 mcg weekly plus standard dose ribavirin 100-1200 mg/day for 48 weeks

Drug: Pegylated interferon alpha-2a

Pegylated interferon alpha-2a 180 mcgs adjusted dose ribavirin

EXPERIMENTAL

Pegylated interferon alpha-2a 180 mcg weekly plus adjusted dose ribavirin for 48 weeks

Drug: Pegylated interferon alpha-2a

Interventions

Pegylated interferon alpha-2aDRUG
Pegylated interferon alpha-2a 180 mcgs adjusted dose ribavirinPegylated interferon alpha-2a plus standard dose ribavirin

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age
  • Naive patients
  • Genotype 4
  • Compensated cirrhosis hepatitis C liver disease (Child-Pugh ≤ 6)
  • Patient needing, according to the physician, the initiation of a combined therapy of pegylated interferon alfa plus Ribavirin
  • Negative HBsAg test and HIV-Elisa test
  • Negative pregnancy test at baseline in women in age of procreation
  • Efficient contraception all along the treatment period, and for 6 months after discontinuation of the treatment for women and men

You may not qualify if:

  • Decompensated Cirrhotic patients
  • HBV or HIV co-infection
  • Evidence of hepatocellular carcinoma
  • Significant and evolutive cardiovascular, pulmonary, severe psychiatric disorder or renal dysfunction (calculated creatinine CL \< 50 ml/min) \*. Patients who met the trial criteria if subsequent calculated creatinine CL \< 50 ml/min may need ribavirin dose reduction.
  • Non compensated thyroid dysfunction
  • Recent history of epilepsy (less than 6 months)
  • Absolute contraindications to one of the drug of combination therapy
  • Any non-compensated cardiac disease including ischemic heart disease Chronic cardiac failure (grade III or IV - NYHA classification)
  • Pregnancy or breast feeding.
  • Post liver transplantation patient with HCV
  • Alcohol or drug induced liver disease.
  • Metabolic or autoimmune liver disease.
  • Hemoglobinopathies or anemia; hemoglobin \<12 gm /dl for females and \<12.5 for males not corrected by erythropoietin
  • Neutropenia (\<1500/mm³)
  • Thrombocytopenia (\<90,000/mm3), thrombocytosis (\> 500,000/mm3)
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

King Faisal Specialist Hospital & Research Centre

Riyadh, 11159, Saudi Arabia

Location

King Abdulaziz Medical City

Riyadh, 11462, Saudi Arabia

Location

King Khaled University Hospital

Riyadh, Saudi Arabia

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

peginterferon alfa-2a

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Hepatologist & Liver Transplant Physician

Study Record Dates

First Submitted

September 13, 2012

First Posted

September 18, 2012

Study Start

January 1, 2011

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

February 24, 2016

Record last verified: 2016-02

Locations

SA(3)