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Atenativ for Antithrombin Deficiency

Phase 3
Recruiting
Research Sponsored by Octapharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Personal or family history of TEs or TEEs
Adult male or female patients ≥18 and ≤80 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up before first infusion, 20 minutes, 1 hour, 3 hours, 8 hrs, 1 day, 2 days, 3, days, 4 days, 5 days, 6 days, 7 days, 8 days, 10 days, 12 days and 14 days post-infusion
Awards & highlights

Study Summary

This trial will assess the incidence of thrombotic events (TEs) and thromboembolic events (TEEs) in patients with congenital antithrombin deficiency under cover of Atenativ for surgical procedures or parturition.

Who is the study for?
This trial is for adults with congenital antithrombin deficiency who need surgery or are giving birth. It includes those aged 18-80, and a small group of minors (12-17) in the US. Pregnant women must be at least 27 weeks along. Exclusions include emergency procedures, recent surgeries, other clotting disorders, high BMI (non-pregnant), drug allergies, nursing mothers, and certain medical conditions.Check my eligibility
What is being tested?
The trial tests Atenativ's effectiveness in preventing blood clots during surgery or childbirth in patients with low antithrombin levels. Participants will receive Atenativ to see if it reduces the risk of thrombotic events.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to Atenativ or its ingredients. Since it's designed to prevent clotting issues, there might also be risks related to bleeding complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I or my family have a history of thromboembolic events.
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I am between 18 and 80 years old.
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I am either scheduled for a high-risk surgery or am pregnant and planning a caesarean section after 27 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~before first infusion, 20 minutes, 1 hour, 3 hours, 8 hrs, 1 day, 2 days, 3, days, 4 days, 5 days, 6 days, 7 days, 8 days, 10 days, 12 days and 14 days post-infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and before first infusion, 20 minutes, 1 hour, 3 hours, 8 hrs, 1 day, 2 days, 3, days, 4 days, 5 days, 6 days, 7 days, 8 days, 10 days, 12 days and 14 days post-infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Thrombosis
Secondary outcome measures
Activated Partial Thromboplastin Time measurement
Coagulation parameters: Fibrinogen level
Coagulation parameters: International normalised ratio [INR]
+10 more

Side effects data

From 2016 Phase 3 trial • 120 Patients • NCT02059135
53%
Hypertension
40%
Headache
33%
Pre-eclampsia
15%
Back pain
15%
Aspartate aminotransferase increased
13%
Thrombocytopenia
12%
Alanine aminotransferase increased
10%
Insomnia
10%
Constipation
8%
Dizziness
8%
Pulmonary oedema
8%
Abdominal pain
8%
Abdominal pain upper
7%
Oedema peripheral
7%
Nausea
7%
Infusion site extravasation
7%
Vomiting
7%
Blood lactate dehydrogenase increased
7%
Hepatic enzyme increased
7%
Neck pain
5%
Epistaxis
5%
Anxiety
3%
HELLP syndrome
3%
Pyrexia
2%
Nasal congestion
2%
Intrapartum haemorrhage
2%
Postpartum haemorrhage
2%
Dyspnoea
2%
Pleural effusion
2%
Pruritus
2%
Ileus
2%
Lobar pneumonia
2%
Postoperative wound infection
2%
Premature separation of placenta
2%
Vision blurred
2%
Platelet count decreased
2%
Postpartum depression
2%
Abdominal Pain
2%
Foetal growth restriction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Maternal/Fetal Safety Population: ATryn
Neonatal Safety Population: Placebo
Maternal/Fetal Safety Population: Placebo (Normal Saline 0.9%)
Neonatal Safety Population: ATryn

Trial Design

1Treatment groups
Experimental Treatment
Group I: Atenativ treatmentExperimental Treatment1 Intervention
Patients will receive a single intravenous infusion of Atenativ for PK analysis. Patients will receive a single intravenous dose followed by maintenance doses administered every 24 hours for approximately 2-7 days for surgical patients and approximately 5 days for parturients

Find a Location

Who is running the clinical trial?

OctapharmaLead Sponsor
84 Previous Clinical Trials
7,820 Total Patients Enrolled

Media Library

Atenativ Clinical Trial Eligibility Overview. Trial Name: NCT04918173 — Phase 3
Antithrombin Deficiency Research Study Groups: Atenativ treatment
Antithrombin Deficiency Clinical Trial 2023: Atenativ Highlights & Side Effects. Trial Name: NCT04918173 — Phase 3
Atenativ 2023 Treatment Timeline for Medical Study. Trial Name: NCT04918173 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who meets the requirements to participate in this experiment?

"This study is only open to people with antithrombin iii deficiency and between the ages of 12-80. So far, 38 candidates have been recruited."

Answered by AI

Are new patients still being sought out for this clinical trial?

"Yes, this study is still looking for volunteers according to the information provided on clinicaltrials.gov. The trial was created on 7/1/2022 and updated as recently as 9/16/2022."

Answered by AI

What is the regulatory status of Atenativ?

"Atenativ's safety is estimated to be a 3. This Phase 3 trial has collected data supporting the efficacy of Atenativ as well as its safety profile after multiple rounds of testing."

Answered by AI

Is this clinical trial widely available in the United States?

"4 active recruitment sites for this study are situated in Washington, Peoria, Miami and other locations. To reduce the burden of travel, participants should enroll at the clinical trial site nearest to them."

Answered by AI

How large is the sample size of this experiment?

"In total, 38 eligible patients are required in order for the trial to commence. Octapharma will sponsor the study from various locations, two of which are Georgetown University and Bleeding and Clotting Disorders Institute."

Answered by AI

Does this research include elderly participants?

"The age requirements to participate in this trial are 12-80. There are 4 sub-studies for patients that fall outside of this bracket, with 2 for those underaged and 2 for seniors."

Answered by AI

What makes this research unique compared to other projects?

"Atenativ was first trialled in 2006. 30 participants were involved in the Phase 1 study which was sponsored by Grifols Biologicals, LLC. After the initial success of the 2006 trial, Atenativ received approval for further clinical trials. There are presently 2 active studies being conducted in 5 cities and 7 countries."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Efficacy of Atenativ in Patients With Congenital Antithrombin Deficiency Undergoing Surgery or Delivery
2022. "Efficacy of Atenativ in Patients With Congenital Antithrombin Deficiency Undergoing Surgery or Delivery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04918173.
~9 spots leftby Dec 2024
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