← Back to Search

RNAi Therapeutics

Prior Patisiran Group of Study 004 for Amyloidosis

Phase 3
Waitlist Available
Research Sponsored by Alnylam Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have completed a patisiran study (i.e., completed the last efficacy visit in the parent study) and, in the opinion of the investigator, tolerated study drug
Be willing and able to comply with the protocol-required visit schedule and visit requirements and provide written informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, year 5
Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and effective for treating a disease where proteins build up and damage the body.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, year 5
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, year 5 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants With Adverse Events (AEs) Leading to Study Discontinuation
Secondary outcome measures
Change From Baseline in the 10-meter Walk Test (10-MWT) Speed at Year 5
Change From Baseline in the Cardiac Biomarker: N-terminal Prohormone of B-type Natriuretic Peptide (NT-proBNP) at Year 5
Change From Baseline in the Cardiac Biomarker: Serum Troponin I at Year 5
+24 more

Side effects data

From 2022 Phase 3 trial • 211 Patients • NCT02510261
32%
Nasopharyngitis
24%
Oedema Peripheral
24%
Limb Injury
20%
Urinary Tract Infection
20%
Flushing
20%
Fall
20%
Cataract
20%
Cough
16%
Dental Caries
16%
Vertigo
16%
Pain in Extremity
16%
Influenza
16%
Back Pain
16%
Infusion Related Reaction
12%
Skin Ulcer
12%
Diarrhoea
12%
Erysipelas
12%
Constipation
12%
Vomiting
12%
Respiratory Tract Infection
12%
Tonsillitis
12%
Vitamin D Deficiency
12%
Pyrexia
12%
Infected Skin Ulcer
12%
Nausea
12%
Musculoskeletal Pain
8%
Ear Pain
8%
Toothache
8%
Malaise
8%
Neuralgia
8%
Anxiety
8%
Renal Failure
8%
Post-traumatic Pain
8%
Hypertension
8%
Traumatic Haematoma
8%
Sinusitis
8%
Tendonitis
8%
Tibia Fracture
8%
Anaemia
8%
Cardiac Failure
8%
Osteoarthritis
8%
Ankle Fracture
8%
Fungal skin infection
8%
Paraesthesia
8%
Gait Disturbance
8%
Gastrooesophageal Reflux Disease
8%
Fatigue
8%
Muscle Spasms
8%
Skin Lesion
8%
Oropharyngeal Pain
8%
Visual Impairment
8%
Localised Infection
8%
Wound Infection
8%
Vertigo Positional
8%
Atrial Flutter
8%
Depression
8%
Urinary Retention
8%
Arthralgia
8%
Orthostatic Hypotension
8%
Syncope
8%
Dermatitis
4%
Thermal Burn
4%
Ligament Sprain
4%
Headache
4%
Atrioventricular Block Complete
4%
Abdominal Pain Upper
4%
Chest Discomfort
4%
Hypokalaemia
4%
Polyp
4%
Dehydration
4%
Metastatic Malignant Melanoma
4%
Upper Respiratory Tract Infection
4%
Sciatica
4%
Cerebral Infarction
4%
Conjunctival Haemorrhage
4%
Neck Pain
4%
Brain Cancer Metastatic
4%
Acute Kidney Injury
4%
Epistaxis
4%
Rash
4%
Atrial Tachycardia
4%
Bone Cancer
4%
Metastases to Meninges
4%
Osteomyelitis
4%
Coronary Artery Stenosis
4%
Conversion Disorder
4%
Weight Decreased
4%
Restrictive Cardiomyopathy
4%
Seizure
4%
Rhinitis
4%
Cerebrovascular Accident
4%
Confusional State
4%
Erythema
4%
Bronchitis
4%
Abdominal Pain
4%
Asthenia
4%
Dizziness
4%
Dysphonia
4%
Myalgia
4%
Benign Prostatic Hyperplasia
4%
Dysuria
100%
80%
60%
40%
20%
0%
Study treatment Arm
Prior Placebo Group of Study 004
Prior Patisiran Group of Study 003
Prior Patisiran Group of Study 004

Trial Design

3Treatment groups
Experimental Treatment
Group I: Prior Placebo Group of Study 004Experimental Treatment1 Intervention
Participants who received placebo and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 milligrams per kilogram (mg/kg) patisiran intravenously (IV) once every 3 weeks (Q3W) up to 65.5 months.
Group II: Prior Patisiran Group of Study 004Experimental Treatment1 Intervention
Participants who received patisiran and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 66.9 months.
Group III: Prior Patisiran Group of Study 003Experimental Treatment1 Intervention
Participants who received patisiran and completed parent study ALN-TTR02-003 (NCT01961921) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 61.4 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Patisiran
2015
Completed Phase 3
~340

Find a Location

Who is running the clinical trial?

Alnylam PharmaceuticalsLead Sponsor
71 Previous Clinical Trials
14,107 Total Patients Enrolled
28 Trials studying Amyloidosis
10,467 Patients Enrolled for Amyloidosis
Medical DirectorStudy DirectorAlnylam Pharmaceuticals
2,772 Previous Clinical Trials
8,062,207 Total Patients Enrolled
12 Trials studying Amyloidosis
3,377 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
The Study of an Investigational Drug, Patisiran (ALN-TTR02), for the Treatment of Transthyretin (TTR)-Mediated Amyloidosis in Participants Who Have Already Been Treated With ALN-TTR02 (Patisiran)
2015. "The Study of an Investigational Drug, Patisiran (ALN-TTR02), for the Treatment of Transthyretin (TTR)-Mediated Amyloidosis in Participants Who Have Already Been Treated With ALN-TTR02 (Patisiran)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02510261.
~22 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top