Health TrialsbyHealthPanel

The Holistic Study

ConditionThrombocytopenia Purpura
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorOstfold Hospital Trust

About this trial

This study is a phase 3 study where eligible patients will be randomized 1:1 to one of two treatment strategies: receiving a thrombopoietin receptor agonist (Avatrombopag), or anti-CD20 (Rituximab).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female aged ≥18 years.

Diagnosis of primary ITP of less than one-year duration and having a platelet count of < 30 x109/L measured within two weeks prior to inclusion with failure to achieve response or relapse after at least one cycle of dexamethasone (20-40 mg daily for 4 days) or prednisone /prednisolone (1 mg/kg for at least two weeks). Shorter courses or lower doses are allowed if discontinued or modified due to side effects.

Clinical need for subsequent platelet elevating therapy assessed by the physician in charge.

Signed and dated written informed consent.

Disqualifiers

Previous treatment for ITP with: Rituximab, other immune suppressants (including mycophenolate mofetil, azathioprine, cyclosporine), dapsone, danazol, chemotherapy (apart from vincristine as rescue therapy) or splenectomy. Short treatment with any thrombopoietic agent is allowed if given for a limited duration of a maximum of 2 weeks as rescue therapy for quick elevation of platelet count in emergency situations e.g. bleeding.

Pregnancy or lactation.

Females of child-bearing potential refusing to follow effective contraceptive methods for at least 12 months following the last administration of Rituximab or during treatment with Avatrombopag.

Secondary ITP: ITP secondary to lymphoma or chronic lymphocytic leukemia; ITP secondary to the following autoimmune disorders: Systemic Lupus Erythematosus, Antiphospholipid Syndrome, or Common Variable Immune Deficiency; ITP secondary the following viral infections: Human Immunodeficiency Virus or Hepatitis C Virus.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Avatrombopag

    Drug

    Daily tablets

  • Rituximab (Arm B)

    Drug

    I.V.

Treatment groups

220 Participants
are divided into 2 treatment groups
Group A: AvatrombopagExperimental treatment 2 interventions
Group B: RituximabActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Efficacy of the oral TPO-RA, Avatrombopag, to Rituximab

To compare the efficacy of the oral TPO-RA, Avatrombopag to Rituximab by measuring the rates of durable responses defined as achieving platelet counts ≥ 50 X109/L in ≥3 of the bi-weekly measurements between weeks 20 and 28 including the last count without having received any other platelet elevating agents after randomization apart from rescue therapy received before end of week 10.

Time frame
Assessed at week 28

Secondary outcomes

1

The changes in the disease specific HRQoL

The changes in the disease specific HRQoL from baseline to weeks 28 and 78 measured by ITP-PAQ (Overall Quality of Life Scale) score.

Time frame
Baseline to weeks 28 and weeks 78
2

Changes in the level of fatigue

The changes in the level of fatigue from baseline to weeks 28 and 78 measured by FACIT-Fatigue score

Time frame
Baseline to weeks 28 and weeks 78
3

Rates of Sustained Response Off-Treatment (SROT)

The rates of Sustained Response Off-Treatment (SROT) at 78 weeks where the occurrence of SROT defined as * A platelet count \> 50 X109/L in at least 3 of the 4 planned visits between weeks 36 and 78 including week 78 * No administration of platelet elevating agent between weeks 36 and 78.

Time frame
At 78 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ostfold Hospital Trust

Lead sponsor

Oslo University Hospital

Collaborator

University Hospital, Akershus

Collaborator

Sykehuset i Vestfold HF

Collaborator

St. Olavs Hospital

Collaborator

Helse Stavanger HF

Collaborator

Sorlandet Hospital HF

Collaborator

University Hospital of North Norway

Collaborator

Haukeland University Hospital

Collaborator

Helse Nord-Trøndelag HF

Collaborator

Helse Fonna

Collaborator

Nordlandssykehuset HF

Collaborator

Source ClinicalTrials.gov

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