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Antisense Oligonucleotide

Inotersen for Amyloidosis

Phase 2
Waitlist Available
Led By Rodney 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 month 24
Awards & highlights

Study Summary

This study is evaluating whether a drug can slow or stop the progression of TTR amyloid cardiomyopathy.

Eligible Conditions
  • Amyloidosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Systolic strain imaging by echocardiographic
Secondary outcome measures
ECV-extracellular volume by Cardiac MRI (cMRI) (unit=percentage)
LV mass measurement by Cardiac MRI (cMRI) (units = grams)
Echocardiography

Side effects data

From 2021 Phase 3 trial • 135 Patients • NCT02175004
29%
Nausea
25%
Diarrhoea
24%
Fatigue
21%
Urinary tract infection
21%
Fall
20%
Chills
19%
Vomiting
19%
Thrombocytopenia
15%
Oedema peripheral
14%
Injection site erythema
14%
Constipation
14%
Injection site pain
13%
Pyrexia
12%
Muscular weakness
11%
Syncope
11%
Anaemia
11%
Dyspnoea
9%
Headache
9%
Arthralgia
9%
Cough
9%
Abdominal pain
8%
Hypotension
8%
Orthostatic hypotension
8%
Dizziness
8%
Pain in extremity
8%
Nasopharyngitis
8%
Injection site pruritus
8%
Weight decreased
7%
Asthenia
7%
Muscle atrophy
7%
Paraesthesia
7%
Insomnia
7%
Hypoaesthesia
7%
Back pain
6%
Rash
6%
Bronchitis
6%
Myalgia
6%
Upper respiratory tract infection
6%
Platelet count decreased
6%
Hypertension
6%
Atrial fibrillation
6%
Balance disorder
6%
Injection site rash
6%
Oedema
6%
Sinusitis
6%
Urinary retention
6%
Dyspepsia
6%
Pneumonia
5%
Decreased appetite
5%
Cataract
5%
Haematuria
5%
Cardiac failure congestive
5%
Influenza
5%
Gait disturbance
5%
Glomerular filtration rate decreased
5%
Injection site bruising
4%
Influenza like illness
4%
Dry eye
4%
Herpes zoster
4%
Cardiac failure
4%
Sepsis
4%
Cellulitis
2%
Subarachnoid haemorrhage
2%
Epistaxis
2%
Cardiac failure acute
2%
Clostridium difficile colitis
2%
Hyponatraemia
2%
Acute kidney injury
1%
Septic shock
1%
Pyelonephritis acute
1%
Cerebrovascular accident
1%
Gastrointestinal haemorrhage
1%
Pancreatitis
1%
Facial bones fracture
1%
Arrhythmia
1%
Ventricular fibrillation
1%
Cardiac tamponade
1%
Bacteraemia
1%
Bacterial toxaemia
1%
Cellulitis streptococcal
1%
Measles
1%
Osteomyelitis
1%
Osteomyelitis chronic
1%
Angina unstable
1%
Gastroenteritis
1%
Wound
1%
Bradycardia
1%
Chest pain
1%
Generalised oedema
1%
Autoimmune hepatitis
1%
Liver disorder
1%
Cholecystitis infective
1%
Endocarditis
1%
Infection
1%
Localised infection
1%
Lower respiratory tract infection
1%
Pneumococcal sepsis
1%
Pneumonia pseudomonal
1%
Pneumonia viral
1%
Skin infection
1%
Systemic infection
1%
Urosepsis
1%
Rib fracture
1%
Spleen contusion
1%
Dehydration
1%
Fluid retention
1%
Lumbar spinal stenosis
1%
Small cell lung cancer
1%
Calculus bladder
1%
Nephrolithiasis
1%
Asphyxia
1%
Hypoxia
1%
Respiratory failure
1%
Decubitus ulcer
1%
Acute pulmonary oedema
1%
Cardiac arrest
1%
Peritoneal haemorrhage
1%
Rectal haemorrhage
1%
Umbilical hernia, obstructive
1%
Biliary cirrhosis primary
1%
Anti-neutrophil cytoplasmic antibody positive vasculitis
1%
Corona virus infection
1%
Femur fracture
1%
Encephalopathy
1%
Memory impairment
1%
Neuropathy peripheral
100%
80%
60%
40%
20%
0%
Study treatment Arm
Previous Placebo-Inotersen 300 mg
Previous Inotersen-Inotersen 300 mg

Trial Design

1Treatment groups
Experimental Treatment
Group I: Experimental DrugExperimental Treatment1 Intervention
Inotersen, a transthyretin (TTR) antisense oligonucleotide. Administered subcutaneously weekly. Each dose shall contain 300 mg of active drug. Subsequent visits will occur at 3, 6, 12, 18 and 24 months. Every 2 weeks, blood will be monitored for renal function and platelet count and urine will be tested by dipstick for proteinuria.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Inotersen
FDA approved

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,616 Previous Clinical Trials
11,470,898 Total Patients Enrolled
9 Trials studying Amyloidosis
741 Patients Enrolled for Amyloidosis
Rodney Falk, MDPrincipal InvestigatorBrigham and Women's Hospital
1 Previous Clinical Trials
171 Total Patients Enrolled
1 Trials studying Amyloidosis
171 Patients Enrolled for Amyloidosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
24 Month Open Label Study of the Tolerability and Efficacy of Inotersen in TTR Amyloid Cardiomyopathy Patients
Rodney H. Falk, MD 2019. "24 Month Open Label Study of the Tolerability and Efficacy of Inotersen in TTR Amyloid Cardiomyopathy Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03702829.
All > Cardiomyopathy
~8 spots leftby May 2025
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