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Antibiotic

TUDCA and Doxycycline for Cardiac amyloidosis

Phase 1 & 2

Waitlist Available

Led By Rodney H Falk, MD

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time frame: * (fdaaa) outcome measure is assessed every 6 months by serial echocardiography, with final measurement 18 months after enrollment, change at 12 months reported as pre-defined primary endpoint.

Awards & highlights

All Individual Drugs Already Approved

Approved for 60 Other Conditions

No Placebo-Only Group

Summary

The objective of the study is to determine whether the combination of the bile acid TUDCA, and doxycycline will slow the progression of familial and senile amyloidosis.

Eligible Conditions

Cardiac amyloidosis
Cardiac Amyloidosis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time frame: * (fdaaa) outcome measure is assessed every 6 months by serial echocardiography, with final measurement 18 months after enrollment, change at 12 months reported as pre-defined primary endpoint.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time frame: * (fdaaa) outcome measure is assessed every 6 months by serial echocardiography, with final measurement 18 months after enrollment, change at 12 months reported as pre-defined primary endpoint.

This trial's timeline: 3 weeks for screening, Varies for treatment, and time frame: * (fdaaa) outcome measure is assessed every 6 months by serial echocardiography, with final measurement 18 months after enrollment, change at 12 months reported as pre-defined primary endpoint. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in Strain Echocardiography

Side effects data

From 2015 Phase 1 & 2 trial • 40 Patients • NCT01855360

15%

gastrointestinal upset

acute kidney injury

100%

80%

60%

40%

20%

Study treatment Arm

TUDCA and Doxycycline

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 60 Other Conditions

This treatment demonstrated efficacy for 60 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: TUDCA and DoxycyclineExperimental Treatment1 Intervention

INTERVENTION: Patients meeting study criteria were prescribed TUDCA taken orally, 250 mg three times daily. and doxycycline taken orally, 100 mg twice daily.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Doxycycline

FDA approved

Do I qualify?Apply below to find out