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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00844272
Other study ID # CIAR-PERMIT
Secondary ID
Status Completed
Phase Phase 4
First received February 12, 2009
Last updated May 27, 2015
Start date May 2005
Est. completion date November 2009

Study information

Verified date May 2015
Source Universitätsklinikum Hamburg-Eppendorf
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial Summary

Study objective: Feasibility and efficacy of a standardised psychosocial intervention (psychoeducation) in substituted opioid dependent patients


Description:

Primary objective:

- Retention in antiviral treatment (feasibility)

Secondary objectives:

- Mental Health Mental health is monitored by means of the Symptom Checklist 90-R (SCL-90-R). Its sum score, the Global Severity Index (GSI), serves as indicator. Mental health will be regarded as stable in case of a change of less than 6 GSI-points, otherwise mental health will be regarded as improved (GSI - 6 points) or decreased (GSI + 6 points).

- Course of Addiction Course of addiction under antiviral treatment will be monitored according to retention in substitution treatment, compliance with scheduled visits, and co-consumption of illicit drugs (patients record, urinalysis).

- Sustained viral response (SVR) SVR as measured by polymerase chain reaction 6 months after per protocol antiviral treatment (ITT-analysis).


Recruitment information / eligibility

Status Completed
Enrollment 189
Est. completion date November 2009
Est. primary completion date November 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Women and men at the age of 18 to 70 years

- Opiate dependence according to ICD-10

- Stable substitution (i.e. either keeping the last 5 dates or fulfilling criteria for the Take Home assignment)

- Proof of HCV by means of PCR

- Patient must be therapy naive regarding the hepatitis C (no preceding treatment attempts with interferon and/or Ribavirin)

- Ability to comprehend und follow the study protocol

- Compensated liver disease with the following haematological and biochemical minimum criteria:

1. Leukocytes = 3.000/mm3

2. Neutrophile granulocytes = 1.500/mm3

3. Thrombocytes = 90.000/mm3

4. Direct and indirect bilirubin within the standard range (if not factors, which are not hepatitis-conditioned, as M. Meulengracht, represent an explanation for the increase of the indirect bilirubin; in these cases the indirect bilirubin must be less than 3.0 mg/dl or 51.3 µmol/l)

5. Albumin within the standard range

6. Creatinine within the standard range

- TSH (Thyreotropine) within the standard range of the test laboratory

- Normal blood sugar value for non-diabetics or haemoglobin A1c max. 8.5% for diabetics (induced by pharmacotherapy and/or diet controls). An eye examination is required in diabetics.

- Haemoglobin values = 12 mg/dl for women and/or = 13 mg/dl for men

- ANA = 1:160

- In patients with cirrhosis or transition to cirrhosis: exclusion of hepatocellular carcinoma

- Readiness to abstain from alcohol during interferon treatment.

- Negative pregnancy test in female patients within 24 hours before the first dose

- Regular confirmation that sexual active women at the age capable of child-bearing and/or sexual active men use two reliable methods of contraception during interferon / ribavirin treatment and six months thereafter, one contraception method with barrier effect (e.g. condom, diaphragm)

- Female patients may not breastfeed during interferon / ribavirin treatment.

Exclusion Criteria:

- Decompensated liver cirrhosis (Child-Pugh B or C)

- Haemochromatosis

- Lack of Alfa-1-Antitrypsin (homozygote - PIZZ)

- Morbus-Wilson

- positive proof of HBsAg, anti- HIV or anti- HAV IgM antibodies

- Autoimmune diseases (e.g. autoimmune hepatitis, autoimmune thyroid disease, rheumatoid arthritis)

- Kidney failure (Creatinine > 1,5 mg/dl)

- Liver- or kidney-transplantation

- Hyperlipidemia (Cholesterol > 1,5-times above the upper standard value)

- Clinically manifested gout

- Severe heart insufficiency

- Severe coronary heart disease

- Patients with cardiac pacemaker

- Severe chronic pulmonary diseases (e.g. COPD)

- Serious psychological illness, in particular severe depression

- Epilepsy

- Oesophagus varicose in the prehistory

- Patient with high anaemia risk (e.g. Thalassaemia)

- Retinopathy

- Severe other illness

- Patients, who cannot follow the study conditions

- Male partners of pregnant women

- Current desire to have children / no safe contraception under therapy and until including 6 months after study end

- Participation in a clinical study within the last 6 months

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Behavioral:
Psychoeducation
Group-therapeutic intervention with 12 sessions plus 5 update sessions with 24-week therapy duration and/or 12 sessions plus 10 update sessions with 48-week therapy duration Module I: Create understanding, resources, problems and solutions Module II: Information on hepatitis C infection Module III: Information on treatment Module IV: Specific information on depression and withdrawal symptoms under interferon The meetings take a minimum of 60 min. time, should be once weekly. The group size should lie between 6 and 12 participants. The group leaders are trained in performance of the psycho-education.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Universitätsklinikum Hamburg-Eppendorf Hoffmann-La Roche

Outcome

Type Measure Description Time frame Safety issue
Primary Retention in antiviral treatment (feasibility) within the first 24/48 weeks No
Secondary Psychological health within the first 24/48 weeks Yes
Secondary Medical process on the basis of retention in substitution treatment within the first 24/48 weeks Yes
Secondary Permanent virus suppression within the first 24/48 weeks Yes
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