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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-005287-27-IT

Enrollment

Registered

2007-10-15

Start date

2007-10-15

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

ATTR amyloidosis MedDRA version: 6.1 Level: PT Classification code 10002022

Interventions

Trade Name: BASSADO Pharmaceutical Form: Tablet INN or Proposed INN: Doxycycline Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age>/=18 years; Laboratory values obtained /=50%; Total bilirubin /= 40 ml/min or creatinine /=100 mmHg (standing); NYHA class =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026