Prospective randomized controlled trial to test efficacy and safety of PEG-IFN alpha-2a/Ribavirin (Copegus) plus Raloxifene hydrochloride for postmenopausal women with chronic hepatitis C.(PCR study)

Prospective randomized controlled trial to test efficacy and safety of PEG-IFN alpha-2a/Ribavirin (Copegus) plus Raloxifene hydrochloride for postmenopausal women with chronic hepatitis C.(PCR study) - PCR-Study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003247

Enrollment

Registered

2010-02-26

Start date

2010-03-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic hepatitis C

Interventions

A:Read-in therapy of Raloxifene hydrochloride 60mg/day for 8 weeks followed by PEG-IFN alpha 2a (90-180 microgram/weekly)+RBV+Raloxifene hydrochloride for 48-72 weeks. B:PEG-IFN alpha 2a (90-180 micr

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1.Chronic hepatitis C patients HBs Ag negative 2.Postmenopausal women 3.Patient who meets the following criteria for laboratory tests. HCV RNA> 5LogIU/ML Neutrophils: >1,500/microL Platelets: >70,000/microL Hemoglobin: >10g/dL BW: >40kg Patients with Informed consent 4.Patients who have signed consent to participate in this research

Exclusion criteria

Exclusion criteria: Patient with 1.Pregnant or lacting women and women who may be pregnant 2.Premenopausal women 3.allergic to ribavirin or nucleoside analogues 4.hemoglobinopathy(thalassemia, sickle cell disease) 5.an uncontrollabl heart trouble(myocardial infarction, heart failure, or arrhythmia) 6.an poorly controlled diabetes mellitus and hypertension 7.severe renal disease, Ccr < 50ml/min 8.severe depression or psychosomatic disorders. 9.autoimmune disease or the doubt 10.clinical laboratory date does not meet selection criterion. 11.drugg allergy against interferon 12.Patient who has previous history of hypersensitivity for biological products such as vaccines 13.Patient who cannot do of prohibition of using together medicine for this treatment period 14.Patient who has deep-vein thrombosis, lung embolism, and venous thromboembolism of retina vein thrombosis etc. or patient who has the previous history. 15.Patient who is a long term and immovable. 16.Patient of antiphospholipid antibody syndrome. 17.Patient who admitted that doctor in charge is improper as object person in present study.

Design outcomes

Primary

Measure	Time frame
Sustained virologic response	—

Countries

Japan

Contacts

Public ContactAkito Nozaki

Yokohama City University Medical Center Gastroenterological Center

akino@yokohama-cu.ac.jp045-261-5656

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026