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Pregnancy Registry to Collect Long-Term Safety Data From Women Treated With HyQvia

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ClinicalTrials.gov Identifier: NCT02556775
Recruitment Status : Active, not recruiting
First Posted : September 22, 2015
Last Update Posted : June 26, 2018
Sponsor:
Collaborator:
Baxalta Innovations GmbH, now part of Shire
Information provided by (Responsible Party):
Shire ( Baxalta now part of Shire )

Brief Summary:
The purpose of this registry is to acquire safety data (including assessment of anti-rHuPH20 antibodies), regarding the course and outcome of pregnancy in women ever treated with HYQVIA. Development of the fetus/infant at birth and for the first 2 years will also be followed.

Condition or disease Intervention/treatment
Exposure During Pregnancy Biological: A licensed human normal immunoglobulin other than HYQVIA for IV or SC infusion or an alternative treatment Biological: HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase]

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 33 Months
Official Title: Pregnancy Registry to Collect Long-Term Safety Data From Women Treated With HyQvia
Actual Study Start Date : December 4, 2015
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Alternative Product Arm
Participant stops HYQVIA treatment (if the participant is still treated) and a licensed human normal immunoglobulin other than HYQVIA for intravenous (IV) or subcutaneous (SC) infusion or an alternative treatment will be administered, as determined by the physician.
Biological: A licensed human normal immunoglobulin other than HYQVIA for IV or SC infusion or an alternative treatment
To be determined by the physician

HYQVIA Arm
Participant continues to receive HYQVIA (Immune Globulin (Human) 10% with recombinant human hyaluronidase (rHuPH20)), according to her treatment regimen.
Biological: HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase]
Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase
Other Name: Hyqvia




Primary Outcome Measures :
  1. Incidence of all serious adverse events (expectant mother and infant) [ Time Frame: 2.75 years ]

Secondary Outcome Measures :
  1. Incidence of non-serious adverse events (expectant mother and infant) [ Time Frame: 2.75 years ]
    Related and not-related to HYQVIA/Human normal immunoglobulin or alternative treatment

  2. Incidence of local/immunologic adverse events (expectant mother) [ Time Frame: Up to approximately 40 weeks, ie throughout pregnancy, and up to 6 months after delivery for final / study close out visit ]
    Including skin changes (such as: local erythema, local pruritus, induration, nodules)

  3. Development of anti-rHuPH20 antibodies (rHuPH20 binding and neutralizing antibodies) (expectant mother) [ Time Frame: Up to approximately 40 weeks, ie throughout pregnancy, and up to 6 months after delivery for final / study close out visit ]
    rHuPH20 binding and neutralizing antibodies

  4. Complications of pregnancy [ Time Frame: Up to approximately 40 weeks, ie throughout pregnancy ]
  5. Fetal growth/development [ Time Frame: Up to approximately 40 weeks, ie throughout pregnancy ]
  6. Outcome of pregnancy [ Time Frame: At or after delivery/end of pregnancy ]
  7. Neonatal assessment [ Time Frame: At or after delivery/end of pregnancy ]
  8. Status of the infant at birth [ Time Frame: At or after delivery/end of pregnancy ]
  9. Growth measurement and charts for the infant [ Time Frame: Up to 2 years ]
  10. Development milestones [ Time Frame: Up to 2 years ]
    Determined by standard test methods for each region


Biospecimen Retention:   Samples Without DNA
Blood samples (plasma) for anti-recombinant human hyaluronidase (rHuPH20) antibodies that remain after study testing is done may be stored and used for additional testing (eg, further evaluation of an abnormal test or an adverse event). Samples will be stored in a coded form for a maximum of 2 years after the final study report has been completed and, subsequently, will be destroyed.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women who became pregnant after ever treated with HYQVIA, and their infant children
Criteria

Inclusion Criteria:

  • For the expectant mother only: Participant became pregnant during or after treatment with HYQVIA
  • Participant/Participant's legally authorized representative is willing to sign an informed consent form (ICF)

Exclusion Criteria:

  • There are no applicable Exclusion Criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02556775


Locations
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United States, North Carolina
QuintilesIMS Plaza Building
Durham, North Carolina, United States, 27703
Czechia
Fakultni nemocnice Kralovske Vinohrady
Praha 10, Czechia, 10034
Germany
Freiburg University Hospital/ Prof. Dr. med. Bodo Grimbacher
Freiburg, Baden-Württemberg, Germany, 79108
Universitaetsklinikum Wuerzburg
Würzburg, Bayern, Germany, 97080
Klinikum St. Georg gGmbH
Leipzig, Sachsen, Germany, 04129
Poland
Wojskowy Instytut Medyczny
Warszawa, Poland, 04-141
Slovakia
Onkologicky ustav svatej Alzbety s.r.o.
Bratislava, Slovakia, 81250
RAFMED s.r.o
Kosice, Slovakia, 04001
Sponsors and Collaborators
Baxalta now part of Shire
Baxalta Innovations GmbH, now part of Shire
Investigators
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Study Director: Shire Director Shire

Additional Information:

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Responsible Party: Baxalta now part of Shire
ClinicalTrials.gov Identifier: NCT02556775     History of Changes
Other Study ID Numbers: 161301
First Posted: September 22, 2015    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018

Additional relevant MeSH terms:
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Immunoglobulins
Antibodies
gamma-Globulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunoglobulin G
Immunologic Factors
Physiological Effects of Drugs