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The Treatment in Pregnancy for Hepatitis C ("TiP-HepC") Registry

ConditionHepatitis C
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorThe Task Force for Global Health

About this trial

Clinical interventions to reduce the risk of vertical transmission of hepatitis C virus (HCV) infection from mother to infant are highly limited. Direct-acting antiviral (DAA) medications have demonstrated excellent safety and efficacy in non-pregnant individuals, but there is a lack of data regarding the safety of these medications in pregnant women and the effectiveness of these medications in reducing mother-to-child transmission. Therefore, although HCV screening during pregnancy is now recommended in many countries, there is no approved treatment for HCV during pregnancy. An observational study is here proposed to assess outcomes of mother-infant pairs exposed to DAAs during pregnancy within a global clinical case registry. Data regarding the exposures and outcomes of mother-infant pairs exposed to DAAs during pregnancy will be solicited and collected from clinical providers, healthcare facilities, HCV treatment programs, and other clinical practices worldwide. Data will be shared and maintained within a secure database, and cumulative data will be analyzed at pre-determined six-month intervals. The primary outcome will be the number and proportion of mother-infant pairs with adverse pregnancy or birth outcomes. The results of this study will inform HCV treatment decisions by clinical providers and programs worldwide.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Documented chronic HCV infection prior to or during pregnancy (positive test for HCV RNA or HCV core antigen)

Documented DAA exposure occurring within 30 days of the estimated date of conception and before the pregnancy outcome (ie, fetal demise, spontaneous abortion, live delivery, etc). Eligible DAA drugs are listed in Appendix 1.

Disqualifiers

None

Trial population

Individuals with chronic HCV infection and documented pregnancy

Trial design

Design model

Other

Time perspective

Retrospective

Treatments tested in this trial

  • Direct Acting Antivirals

    Drug

    Direct-acting antiviral exposure during documented pregnancy

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Number of adverse pregnancy outcomes

The primary outcomes measured in the study are adverse pregnancy and birth outcomes documented at the time of the outcome of the pregnancy (primary endpoint). Primary adverse pregnancy outcomes include preterm delivery (\<37 weeks gestational age), stillbirth or fetal demise, and maternal death.

Time frame
1 year
2

Number of adverse birth outcomes

Primary adverse birth outcomes include low birth weight (\<2500g), small for gestational age, need for neonatal intensive care, and presence of congenital anomaly.

Time frame
1 year

Secondary outcomes

1

Proportion of registry participants achieving SVR12

Secondary outcomes of the study are the proportion of women achieving HCV cure by HCV PCR test 12 weeks following last DAA treatment (SVR12)

Time frame
12 weeks
2

Proportion of infants with HCV infection

proportion of infants with evidence of chronic HCV infection after 2 months of age by HCV PCR or after 18 months of age by anti-HCV antibody seropositivity

Time frame
18 months

Other outcomes

Sponsors and contacts

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

The Task Force for Global Health

Lead sponsor

Centers for Disease Control and Prevention

Collaborator

Source ClinicalTrials.gov
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