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Thrombopoietin Receptor Agonist

Avatrombopag for Thrombocytopenia

Q: Does this clinical trial use cutting-edge techniques?

Since 2018, Avatrombopag has been the subject of 11 clinical trials in 78 cities and 11 countries.

Q: What is the Avatrombopag FDA status?

There is pre-existing clinical evidence affirming Avatrombopag's safety, thus it received a 3.

Q: What is the efficacy of Avatrombopag when compared to other drugs?

Currently, there are 11 ongoing studies investigating Avatrombopag. Out of these, 3 trials are in the last stage before FDA approval. Most of the research is being conducted in Manchester, England; however, there are 216 total locations running clinical trials for this medication.

Q: What is the uppermost limit of people who can join this research project?

Unfortunately, this study is no longer looking for participants. Although it was active at some point between October 12th 2018 and November 22nd 2021, it is not presently running. There are 123 other studies currently enrolling patients with thrombocytopenia and 11 more that use Avatrombopag if you're interested in finding an alternative clinical trial.

Phase 3

Waitlist Available

Research Sponsored by Dova Pharmaceuticals

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 randomization up to 33 days

Awards & highlights

Study Summary

This trial will test whether avatrombopag can help treat chemotherapy-induced thrombocytopenia in patients with ovarian, lung, or bladder cancer.

Eligible Conditions

Chemotherapy-induced Thrombocytopenia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ randomization up to 33 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~randomization up to 33 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and randomization up to 33 days 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 Subjects Who do Not Require Platelet Transfusion, Dose Reduction in Chemotherapy by 15%, or Chemotherapy Delay by >=4 Days

Secondary outcome measures

Change in Platelet Count From Baseline (Nadir)

Duration of Severe Thrombocytopenia Defined as a Platelet Count <50 x 10^9/L

Percentage of Subjects Who Did Not Have Major or Non-major Clinically Relevant Bleeding During the Period After Post-chemotherapy Study Drug Treatment in Cycle X+1 Through Chemotherapy Day of Cycle X+2.

Side effects data

From 2014 Phase 3 trial • 49 Patients • NCT01438840

38%

Headache

31%

Contusion

19%

Upper respiratory tract infection

13%

Gingival bleeding

13%

Arthralgia

13%

Fatigue

13%

Epistaxis

13%

Petechiae

Nasopharyngitis

Insomnia

Mouth Haemorrhage

Nausea

Back pain

Influenza

Anaemia

Thrombocytopenia

Vomiting

Blood gastrin increased

Cough

Hypertension

Dyspepsia

Mouth haemorrhage

Cerebrovascular accident

Food poisoning

Polyserositis

Uterine haemorrhage

Urinary tract infection

Platelet count decreased

Deep vein thrombosis

Pain in extremity

100%

80%

60%

40%

20%

Study treatment Arm

Avatrombopag (Core Study)

Avatrombopag (Extension Phase)

Placebo (Core Study)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: AvatrombopagExperimental Treatment1 Intervention

Study is 2:1 randomization ratio (avatrombopag to placebo). Investigational product administered orally once daily for 5 days prior to chemotherapy and 5 days following chemotherapy treatment.

Group II: PlaceboPlacebo Group1 Intervention

Study is 2:1 randomization ratio (avatrombopag to placebo). Investigational product administered orally once daily for 5 days prior to chemotherapy and 5 days following chemotherapy treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Avatrombopag

2016

Completed Phase 3

~490

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Dova PharmaceuticalsLead Sponsor

5 Previous Clinical Trials

189 Total Patients Enrolled

5 Trials studying Thrombocytopenia

189 Patients Enrolled for Thrombocytopenia

Sobi, Inc.Lead Sponsor

12 Previous Clinical Trials

505 Total Patients Enrolled

9 Trials studying Thrombocytopenia

240 Patients Enrolled for Thrombocytopenia

Frequently Asked Questions

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

Does this clinical trial use cutting-edge techniques?

"Since 2018, Avatrombopag has been the subject of 11 clinical trials in 78 cities and 11 countries."

Answered by AI

What is the Avatrombopag FDA status?

"There is pre-existing clinical evidence affirming Avatrombopag's safety, thus it received a 3."

Answered by AI

What is the efficacy of Avatrombopag when compared to other drugs?

"Currently, there are 11 ongoing studies investigating Avatrombopag. Out of these, 3 trials are in the last stage before FDA approval. Most of the research is being conducted in Manchester, England; however, there are 216 total locations running clinical trials for this medication."

Answered by AI

What is the uppermost limit of people who can join this research project?

"Unfortunately, this study is no longer looking for participants. Although it was active at some point between October 12th 2018 and November 22nd 2021, it is not presently running. There are 123 other studies currently enrolling patients with thrombocytopenia and 11 more that use Avatrombopag if you're interested in finding an alternative clinical trial."

Answered by AI

Recent research and studies

The Lancet HaematologyJournal

Avatrombopag for Chemotherapy-induced Thrombocytopenia in Patients with Non-haematological Malignancies: An International, Randomised, Double-blind, Placebo-controlled, Phase 3 Trial

Al-Samkari, Hanny, Jaroslaw Kolb-Sielecki, Sufiia Z Safina, Xiaoqiang Xue, and Brian D Jamieson. 2022. “Avatrombopag for Chemotherapy-induced Thrombocytopenia in Patients with Non-haematological Malignancies: An International, Randomised, Double-blind, Placebo-controlled, Phase 3 Trial”. The Lancet Haematology. Elsevier BV. doi:10.1016/s2352-3026(22)00001-1.

clinicaltrials.govStudy

Avatrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Adults With Active Non-Hematological Cancers

2018. "Avatrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Adults With Active Non-Hematological Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03471078.