A Phase II Multicenter Pilot Study of the Safety and Efficacy of Doxycycline on disease progression in early to moderate ATTR amyloidosis - ND

Conditions: ATTR amyloidosis
MedDRA version: 6.1Level: PTClassification code 10002022

Registration Number: EUCTR2007-005287-27-IT

Lead Sponsor: OSPEDALE POLICLINICO S. MATTEO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

Age>/=18 years; Laboratory values obtained /=50%; Total bilirubin /= 40 ml/min or creatinine /=100 mmHg (standing); NYHA class Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Prior liver transplantation or liver transplantation anticipated in < 1 year. Any of the following: Uncontrolled infection; Any known active inflammatory process; Significant acute gastrointestinal symptoms; Active peptic ulceration and/or esophageal reflux disease; history of drug hypersensitivity; Smokers; psychiatric illness; Social situations that would limit compliance with study requirements (e.g.: history of drug abuse); Any of the following: Pregnant or Nursing women; Initiation of or any changes in other medications/supportive therapy (excluding vitamins) within 3 months prior to enrollment; other neuropathies.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To establish the clinical efficacy, in terms of response rate, of doxycycline in ATTR;Secondary Objective: The following variables will be assessed and evaluated in all patients: Safety profile, Time to progression of amyloidosis-associated clinical symptoms and/or organ dysfunction, Duration of ''response'';Primary end point(s): Response is the primary endpoint and will be evaluated according to response criteria.

Secondary Outcome Measures