DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Safety and Efficacy Study of Doxycycline/UrsoDeoxyCholicAcid on Disease Progression in ATTR Amyloidosis

Information source: Umeå University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Transthyretin Amyloidosis; Cardiomyopathy

Intervention: Doxycycline (Drug); Ursodeoxycholic acid (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Umeå University

Official(s) and/or principal investigator(s):
Ole B Suhr, MD PhD Prof, Principal Investigator, Affiliation: Dept of Clinical Medicine and public Health, UmeƄ University

Summary

The primary objective for this study is to evaluate the efficacy of doxycycline + ursodeoxycholic acid (UDCA) on disease progression in Transthyretin Amyloidosis (ATTR) subjects with cardiomyopathy with or without neuropathy.

Clinical Details

Official title: A Phase II Multicenter Pilot Study of the Safety and Efficacy of Doxycycline/UrsoDeoxyCholicAcid on Disease Progression in ATTR Amyloidosis

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The efficacy on serum N terminal proBNP (NT-proBNP)

Secondary outcome:

Modified Body Mass Index (mBMI) reduction

Increase of septum thickness

Neurologic Kumamoto Scale

Number of patients with adverse events

Blood work for potential drug-related adverse events

Eligibility

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Cardiomyopathy with septal thickness > 15 mm and/or S-NT-ProBNP > 300 ng/

- Age >50 years

- Male and females after menopause. Menopause is defined as 6 to 12 months of

amenorrhea in a woman over 45 years of age.

- Written informed consent to be obtained prior to any study procedure

- Histochemical diagnosis of amyloidosis as based on detection by polarizing microscopy

of green birefringent material in Congo red-stained tissue specimens, and typing of amyloid deposits as TTR and identification of amyloid fibril type.

- Molecular definition of the TTR mutation or immunohistochemical staining of amyloid

fibrils with anti TTR antibody

- New York Heart Association (NYHA) class

- Systolic blood pressure >100 mmHg (standing)

- Must have symptomatic organ involvement with amyloid to justify therapy

Exclusion Criteria:

- Liver transplantation in the previous 6 months or liver transplantation anticipated

in less than 6 months;

- ALT and/or AST > 2 x upper normal limit (UNL);

- Creatinine clearance < 30 ml/min (Cockcroft -Gault Formula)

- Any other lab values, illness or condition that in the opinion of the investigator

might place the subject at unacceptable risk for participation in the study;

- History of hypersensitivity to any of the ingredients of the study therapies;

- Use of any investigational drug, device (or biologic) within 4 weeks prior to study

entry or during the study.

Locations and Contacts

Dept of Clinical Medicin, PtieƄ Hospital, PiteƄ SE-941 28, Sweden

Dept of clinical medicin, SkellefteƄ Hospital, SkellefteƄ SE-931 86, Sweden

Dept of Clinical Medicine, UmeƄ University Hospital, UmeƄ SE-90185, Sweden

Additional Information

Starting date: February 2012
Last updated: August 21, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017