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Tyrosine Kinase Inhibitor

Pazopanib for Hereditary Hemorrhagic Telangiectasia (Paz Trial)

Phase 2 & 3

Recruiting

Led By James Gossage, MD

Research Sponsored by Cure HHT

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 epistaxis severity - average of last 6 weeks of study compared to baseline 6 weeks; change in ess at 12, 24 and 48 weeks (versus baseline)

Awards & highlights

Paz Trial Summary

This trial will test if Pazopanib, taken daily for 24 weeks, can reduce nose bleed severity and duration in HHT patients. Tests will also measure blood loss and safety.

Who is the study for?

This trial is for individuals with hereditary hemorrhagic telangiectasia (HHT) who experience severe nosebleeds and anemia. Participants must be able to monitor their blood pressure at home, not start new HHT therapies during the study, and women of childbearing age must use effective contraception. People with certain medical conditions or on prohibited medications cannot join.Check my eligibility

What is being tested?

The trial tests if Pazopanib can reduce nosebleed severity in HHT patients over a 24-week period compared to a placebo. It also monitors blood loss and safety. Patients will take the drug daily and have regular check-ups to assess the impact on their condition.See study design

What are the potential side effects?

While specific side effects are not listed here, common ones associated with Pazopanib may include high blood pressure, diarrhea, hair color changes, nausea, weight loss, fatigue, and liver issues.

Paz Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ epistaxis severity - average of last 6 weeks of study compared to baseline 6 weeks; change in ess at 12, 24 and 48 weeks (versus baseline)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~epistaxis severity - average of last 6 weeks of study compared to baseline 6 weeks; change in ess at 12, 24 and 48 weeks (versus baseline)

This trial's timeline: 3 weeks for screening, Varies for treatment, and epistaxis severity - average of last 6 weeks of study compared to baseline 6 weeks; change in ess at 12, 24 and 48 weeks (versus baseline) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in epistaxis duration in minutes

Hemoglobin Response rate increase in hemoglobin

Secondary outcome measures

Achievement of meaningful improvement in epistaxis for HHT patients

Assess pharmacokinetics and pharmacodynamics (PK/PD) of treatment

Assess the safety of up to 24 and 48 weeks of treatment of pazopanib

+2 more

Other outcome measures

Assess effect of up to 24 and 48 weeks of pazopanib treatment on level of epistaxis severity

Assess effects of up to 24 weeks of pazopanib treatment on epistaxis duration

Assess effects of up to 24 weeks of pazopanib treatment on epistaxis symptom elements

+10 more

Side effects data

From 2019 Phase 2 trial • 30 Patients • NCT01466972

53%

Fatigue

50%

Nausea

37%

Diarrhea

33%

Back pain

30%

Hypertension

30%

Anorexia

23%

Abdominal pain

20%

Bone pain

17%

Dyspnea

17%

Vomiting

17%

Headache

17%

Aspartate aminotransferase increased

13%

Arthralgia

13%

Constipation

13%

Palmar-plantar erythrodysesthesia syndrome

13%

Alanine aminotransferase increased

13%

Investigations - Other

10%

Anemia

10%

Blurred vision

10%

Chills

10%

Pain in extremity

10%

Hot flashes

10%

Dysgeusia

10%

Rash maculo-papular

10%

Alkaline phosphatase increased

Urinary incontinence

Platelet count decreased

Alopecia

Skin and subcutaneous tissue disorders - Other

Neutrophil count decreased

Urinary frequency

Cough

Urinary tract pain

White blood cell decreased

Dry Mouth

Gastroesophageal reflux disease

Fever

Dyspepsia

Non-cardiac chest pain

Hypothyroidism

Hyperglycemia

Hyponatremia

Peripheral motor neuropathy

Blood bilirubin increased

Pleural effusion

Hypotension

Back Pain

Thromboembolic event

Heart Failure

Small intestinal obstruction

Vertigo

100%

80%

60%

40%

20%

Study treatment Arm

Pazopanib in Combination With a NSAI

Paz Trial Design

5Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Part C Pazopanib - 150 mgExperimental Treatment1 Intervention

Pazopanib 150 mg oral daily dosing (six 25 mg Pazopanib capsules).

Group II: Part B (Severe Anemia) Pazopanib - 150 mgActive Control1 Intervention

150 mg pazopanib oral capsules (six 25 mg placebo capsules daily).

Group III: Part B (Severe Epistaxis) Pazopanib - 150 mgActive Control1 Intervention

Pazopanib 150 mg oral daily dosing (six 25 mg Pazopanib capsules).

Group IV: Part B (Severe Anemia) PlaceboPlacebo Group1 Intervention

Placebo oral capsules (six 25 mg placebo capsules daily).

Group V: Part B (Severe Expistaxis) PlaceboPlacebo Group1 Intervention

Placebo oral capsules (six 25 mg placebo capsules daily).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pazopanib

2012

Completed Phase 4

~1370

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Food and Drug Administration (FDA)FED

171 Previous Clinical Trials

1,331,536 Total Patients Enrolled

Cure HHTLead Sponsor

3 Previous Clinical Trials

10,317 Total Patients Enrolled

United States Department of DefenseFED

865 Previous Clinical Trials

327,629 Total Patients Enrolled

Media Library

Pazopanib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03850964 — Phase 2 & 3

Nosebleed Research Study Groups: Part B (Severe Anemia) Pazopanib - 150 mg, Part B (Severe Anemia) Placebo, Part B (Severe Epistaxis) Pazopanib - 150 mg, Part C Pazopanib - 150 mg, Part B (Severe Expistaxis) Placebo

Nosebleed Clinical Trial 2023: Pazopanib Highlights & Side Effects. Trial Name: NCT03850964 — Phase 2 & 3

Pazopanib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03850964 — Phase 2 & 3

Frequently Asked Questions

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

Is there an upper age limit for individuals wishing to participate in this experiment?

"For this research, candidates must have surpassed the age of legal consent and not yet reached their 80th birthday."

Answered by AI

Am I a viable candidate for enrollment in this medical experiment?

"This study has room for up to 70 individuals who are between 18 and 80 years old. Eligibility requirements include presenting with a nosebleed at the time of enrollment."

Answered by AI

Is this investigation open to recruitment at present?

"Affirmative. Clinicaltrials.gov indicates that this medical experiment, first posted on May 1st 2023 and subsequently updated, is still recruiting participants."

Answered by AI

How many subjects are enlisted in this clinical trial?

"Indeed, the clinicaltrials.gov website confirms that this trial is still recruiting volunteers. It was initially posted on May 1st 2023 and it's latest update was also on 5/1/2023. The study requires 70 participants to be recruited at a single site."

Answered by AI

To what diseases or ailments is Pazopanib typically administered?

"As a primary treatment for advanced soft tissue sarcoma (STS), pazopanib has been found to successfully address other medical issues such as advanced thyroid cancer, vaginal itching, and burning sensation."

Answered by AI

Has the efficacy of Pazopanib been tested in other medical trials?

"Currently, there are 32 ongoing clinical trials of pazopanib. Of those studies 7 have entered the later stages (Phase 3). Most research is centered in Chicago but other 1571 locations across America are also hosting their own investigations into this drug's efficacy."

Answered by AI

What is the main purpose of this medical experiment?

"The primary aim of this clinical trial, measured over the last 6 weeks of baseline versus 19-24th week is to gauge a shift in epistaxis duration (in minutes). Secondary goals include evaluating fluctuations in average bleed frequency (noted by electronic record), number of bleeds per day, cumulative amount during 3-week intervals; boosting/enhancing composite physical quality of life score based on Short Form Health Survey 36 [0 - 100 scale with higher values denoting improved self-reported perception regarding physical health; 7 point change considered clinically significant], and assessing changes in blood transfusion frequency through total packed red blood cells within 6 week periods."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effects of Pazopanib on Hereditary Hemorrhagic Telangiectasia Related Epistaxis and Anemia (Paz)

2023. "Effects of Pazopanib on Hereditary Hemorrhagic Telangiectasia Related Epistaxis and Anemia (Paz)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03850964.

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