Condition category
Infections and Infestations
Date applied
03/05/2006
Date assigned
02/06/2006
Last edited
25/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Shin-Hai Tsai

ORCID ID

Contact details

Number 250 Wu-Xing Street
TAIPEI
110
Taiwan

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Since there is no hepatitis C vaccine available for primary prevention, health education is the most important control strategy in containing the impact of hepatitis C. The hypothesis of this study is that effective patient support programs could improve the compliance to treatment and outcome of hepatitis C patients.

Ethics approval

The institutional review board approved the protocol and all patients provided a written informed consent. The date and reference number of ethical approval for our trial is 10/10/2004 and F-950208.

Study design

Interventional randomised controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Chronic hepatitis C

Intervention

All patients who met these criteria randomly chose to be serviced in either of the following two groups:
Group 1 with public health nurse consultation in the outpatient clinic.
Group 2 was offered phone consultation via a health communication center whenever patients needed. Trained healthcare professionals including four nurses and one physician backup at the communication center made a series of structured, scheduled supportive phone calls to patients throughout their treatment period. Additional support was offered to patients to call the healthcare professionals at any time if they have questions. Treating physicians were notified periodically by the health communication center through built-in standardized reminder forms.

All patients were treated with standard therapy. Patients were followed up for 72 weeks. Demographic, laboratory, adverse events, dropout rate and cost data were collected and analyzed.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Sustained virologic response (absence of detectable HCV RNA at the end of follow-up with PCR assay)

Secondary outcome measures

1. Serum alanine aminotransferase
2. Aspartate aminotransferase
3. Dropout rate (the number of patients who discontinued treatment prematurely or were lost to follow-up)

Overall trial start date

01/01/2004

Overall trial end date

30/06/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Adult patients who have never received interferon and who had at least 2000 copies of HCV ribonucleic acid per ml (RNA/ml) of serum with polymerase chain reaction (PCR) assay, serum aspartate aminotransferase (AST) above the upper limit of normal within six months before entry into study and a liver biopsy result consistent with the diagnosis of chronic hepatitis C.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

500

Participant exclusion criteria

Patients with:
1. Neutropenia (<1500/ml of neutrophils)
2. Anemia (Hb <12g/dl of hemoglobin)
3. Thrombocytopenia (platelet <90000/ml)
4. Human immunodeficiency virus (HIV) infection
5. Decompensated liver disease
6. Serum creatinine >1.5 times the upper limit of normal
7. Poorly-controlled psychiatric disease
8. Unwilling to receive contraception

Recruitment start date

01/01/2004

Recruitment end date

30/06/2005

Locations

Countries of recruitment

Taiwan

Trial participating centre

Number 250 Wu-Xing Street
TAIPEI
110
Taiwan

Sponsor information

Organisation

Department of Health (Taiwan)

Sponsor details

Number 100 Aiguo E. Road
Jhongjheng District
Taipei
10092
Taiwan

Sponsor type

Government

Website

http://www.doh.gov.tw

Funders

Funder type

Government

Funder name

Department of Health (Taiwan) (ref: DOH94-TD-B-111-002)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Health Research Institute (Taiwan) (ref: NHRI-EX95-9106PN)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes